Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 8 for:    NAFCILLIN AND cloxacillin

Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment (RENSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01104662
Recruitment Status : Terminated (Cubist has reached an agreement with the FDA that enrollment in the DAP-RENSE-08-05 study can stop.)
First Posted : April 15, 2010
Results First Posted : May 13, 2015
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Complicated Skin and Skin Structure Infections
S. Aureus Bacteremia
Renal Impairment
Interventions Drug: Vancomycin
Drug: Daptomycin
Drug: Semi-Synthetic Penicillin
Enrollment 92
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Daptomycin, Bacteremia, Severe Renal Impairment Vancomycin or SSP, Bacteremia, Severe Renal Impairment Daptomycin, Bacteremia, Moderate Renal Impairment Vancomycin or SSP, Bacteremia, Moderate Renal Impairment Daptomycin, cSSSI, Severe Renal Impairment Vancomycin or SSP, cSSSI, Severe Renal Impairment Daptomycin, cSSSI, Moderate Renal Impairment Vancomycin or SSP, cSSSI, Moderate Renal Impairment
Hide Arm/Group Description Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion. Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin/semi-synthetic penicillin (SSP; for example, nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion. Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion. Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion. Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For complicated skin and skin structure infections (cSSSI) participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion. Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion. Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion. Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
Period Title: Overall Study
Started 20 21 5 4 15 16 5 6
Received at Least 1 Dose of Study Drug 17 17 4 4 15 15 5 6
Completed 10 11 4 3 14 12 5 6
Not Completed 10 10 1 1 1 4 0 0
Reason Not Completed
Adverse Event             2             2             0             1             1             1             0             0
Clinical Failure             1             0             0             0             0             1             0             0
Participant left investigator’s care             1             1             0             0             0             0             0             0
Reason not specified             3             3             0             0             0             1             0             0
Randomized but not treated             3             4             1             0             0             1             0             0
Arm/Group Title Daptomycin, Bacteremia, Severe Renal Impairment Vancomycin or SSP, Bacteremia, Severe Renal Impairment Daptomycin, Bacteremia, Moderate Renal Impairment Vancomycin or SSP, Bacteremia, Moderate Renal Impairment Daptomycin, cSSSI, Severe Renal Impairment Vancomycin or SSP, cSSSI, Severe Renal Impairment Daptomycin, cSSSI, Moderate Renal Impairment Vancomycin or SSP, cSSSI, Moderate Renal Impairment Total
Hide Arm/Group Description Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion. Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion. Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion. Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion. Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion. Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion. Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion. Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion. Total of all reporting groups
Overall Number of Baseline Participants 17 17 4 4 15 15 5 6 83
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 4 participants 4 participants 15 participants 15 participants 5 participants 6 participants 83 participants
LTE18
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BTWN
14
  82.4%
12
  70.6%
1
  25.0%
3
  75.0%
11
  73.3%
11
  73.3%
1
  20.0%
3
  50.0%
56
  67.5%
GTE65
3
  17.6%
5
  29.4%
3
  75.0%
1
  25.0%
4
  26.7%
4
  26.7%
4
  80.0%
3
  50.0%
27
  32.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 4 participants 4 participants 15 participants 15 participants 5 participants 6 participants 83 participants
Female
7
  41.2%
5
  29.4%
2
  50.0%
2
  50.0%
5
  33.3%
3
  20.0%
3
  60.0%
1
  16.7%
28
  33.7%
Male
10
  58.8%
12
  70.6%
2
  50.0%
2
  50.0%
10
  66.7%
12
  80.0%
2
  40.0%
5
  83.3%
55
  66.3%
1.Primary Outcome
Title Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations Through End of Therapy/Early Termination (EOT/ET)
Hide Description The number of participants with CPK elevations of >500 units per liter (U/L) above baseline at any time from Day 1 through the EOT/ET visit are presented.
Time Frame Baseline through EOT/ET
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study drug and had a baseline CPK value and at least 1 post-baseline CPK assessment between Day 1 post-dosing and EOT visit.
Arm/Group Title Daptomycin, Bacteremia, Severe Renal Impairment Vancomycin or SSP, Bacteremia, Severe Renal Impairment Daptomycin, Bacteremia, Moderate Renal Impairment Vancomycin or SSP, Bacteremia, Moderate Renal Impairment Daptomycin, cSSSI, Severe Renal Impairment Vancomycin or SSP, cSSSI, Severe Renal Impairment Daptomycin, cSSSI, Moderate Renal Impairment Vancomycin or SSP, cSSSI, Moderate Renal Impairment
Hide Arm/Group Description:
Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
Overall Number of Participants Analyzed 16 14 3 4 14 13 5 4
Measure Type: Number
Unit of Measure: participants
0 1 0 0 1 0 0 0
2.Secondary Outcome
Title Overall Therapeutic Outcome at Test of Cure (TOC)/Safety Visit
Hide Description

Participants were assigned a Sponsor-assessed clinical outcome based on the following definitions at the TOC/Safety visit:

Failure: Assessed as a failure at any time by the Investigator or received non-study antimicrobial therapy for lack of efficacy or had the primary site of infection removed completely by surgery or underwent surgery to treat the infection >4 days after starting study medication.

Success: Were not assessed as a failure at any time and were assessed as a cure or improvement by the Investigator at the TOC visit.

Non-evaluable: Received potentially effective antimicrobial therapy during the study period for reasons other than lack of efficacy or received <4 days of study medication or were not assessed by the Investigator.

Time Frame Baseline through TOC/Safety Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study drug and had at least 1 Gram-positive baseline infecting pathogen for cSSSI participants or S. aureus bacteremia for bacteremia participants.
Arm/Group Title Daptomycin, Bacteremia, Severe Renal Impairment Vancomycin or SSP, Bacteremia, Severe Renal Impairment Daptomycin, Bacteremia, Moderate Renal Impairment Vancomycin or SSP, Bacteremia, Moderate Renal Impairment Daptomycin, cSSSI, Severe Renal Impairment Vancomycin or SSP, cSSSI, Severe Renal Impairment Daptomycin, cSSSI, Moderate Renal Impairment Vancomycin or SSP, cSSSI, Moderate Renal Impairment
Hide Arm/Group Description:
Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion
Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
Overall Number of Participants Analyzed 15 16 4 4 15 15 5 6
Measure Type: Number
Unit of Measure: participants
Success 9 9 1 3 10 9 5 4
Failure 2 1 2 0 3 2 0 2
Non-evaluable 4 6 1 1 2 4 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Daptomycin, Bacteremia, Severe Renal Impairment Vancomycin or SSP, Bacteremia, Severe Renal Impairment Daptomycin, Bacteremia, Moderate Renal Impairment Vancomycin or SSP, Bacteremia, Moderate Renal Impairment Daptomycin, cSSSI, Severe Renal Impairment Vancomycin or SSP, cSSSI, Severe Renal Impairment Daptomycin, cSSSI, Moderate Renal Impairment Vancomycin or SSP, cSSSI, Moderate Renal Impairment
Hide Arm/Group Description Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.) Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion. Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion. Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion. Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion. Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion. Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion. Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
All-Cause Mortality
Daptomycin, Bacteremia, Severe Renal Impairment Vancomycin or SSP, Bacteremia, Severe Renal Impairment Daptomycin, Bacteremia, Moderate Renal Impairment Vancomycin or SSP, Bacteremia, Moderate Renal Impairment Daptomycin, cSSSI, Severe Renal Impairment Vancomycin or SSP, cSSSI, Severe Renal Impairment Daptomycin, cSSSI, Moderate Renal Impairment Vancomycin or SSP, cSSSI, Moderate Renal Impairment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Daptomycin, Bacteremia, Severe Renal Impairment Vancomycin or SSP, Bacteremia, Severe Renal Impairment Daptomycin, Bacteremia, Moderate Renal Impairment Vancomycin or SSP, Bacteremia, Moderate Renal Impairment Daptomycin, cSSSI, Severe Renal Impairment Vancomycin or SSP, cSSSI, Severe Renal Impairment Daptomycin, cSSSI, Moderate Renal Impairment Vancomycin or SSP, cSSSI, Moderate Renal Impairment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/17 (11.76%)      6/17 (35.29%)      2/4 (50.00%)      1/4 (25.00%)      1/15 (6.67%)      5/15 (33.33%)      0/5 (0.00%)      2/6 (33.33%)    
Blood and lymphatic system disorders                 
Leukocytosis  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
Cardiac disorders                 
Cardiac valve disease  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Cardio-respiratory arrest  1 [1]  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Cardiac failure congestive  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Mitral valve incompetence  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Myocardial infarction  1  2/17 (11.76%)  2 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Ventricular fibrillation  1 [1]  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal disorders                 
Diarrhoea  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Haematemesis  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Abdominal hernia  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Vomiting  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Hepatobiliary disorders                 
Cholelithiasis  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations                 
Cellulitis  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/5 (0.00%)  0 1/6 (16.67%)  1
Clostridium difficile colitis  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
Endocarditis  1  1/17 (5.88%)  2 2/17 (11.76%)  2 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Graft infection  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Klebsiella bacteraemia  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
Osteomyelitis  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
Sepsis  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Arthritis bacterial  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Septic shock  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Injury, poisoning and procedural complications                 
Arteriovenous fistula site haemorrhage  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Foot fracture  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
Graft complication  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Hip fracture  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
Investigations                 
White blood cell count increased  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
Metabolism and nutrition disorders                 
Hyperkalaemia  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders                 
Compartment syndrome  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Psychiatric disorders                 
Mental status changes  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Pulmonary oedema  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Respiratory distress  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Respiratory failure  1  1/17 (5.88%)  1 0/17 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Surgical and medical procedures                 
Thrombolysis  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders                 
Haematoma  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Hypertension  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Hypotension  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
[1]
Resulted in one participant death.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Daptomycin, Bacteremia, Severe Renal Impairment Vancomycin or SSP, Bacteremia, Severe Renal Impairment Daptomycin, Bacteremia, Moderate Renal Impairment Vancomycin or SSP, Bacteremia, Moderate Renal Impairment Daptomycin, cSSSI, Severe Renal Impairment Vancomycin or SSP, cSSSI, Severe Renal Impairment Daptomycin, cSSSI, Moderate Renal Impairment Vancomycin or SSP, cSSSI, Moderate Renal Impairment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/17 (52.94%)      15/17 (88.24%)      4/4 (100.00%)      4/4 (100.00%)      4/15 (26.67%)      5/15 (33.33%)      2/5 (40.00%)      4/6 (66.67%)    
Blood and lymphatic system disorders                 
Anaemia  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Eosinophilia  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Cardiac disorders                 
Angina pectoris  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Atrial fibrillation  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Atrial flutter  1  0/17 (0.00%)  0 1/17 (5.88%)  1 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Atrioventricular block complete  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Atrioventricular block first degree  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Atrioventricular block second degree  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Tachycardia  1  0/17 (0.00%)  0 1/17 (5.88%)  2 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Eye disorders                 
Eye inflammation  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Eye pain  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Vision blurred  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal disorders                 
Abdominal discomfort  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Abdominal hernia  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Abdominal pain  1  0/17 (0.00%)  0 2/17 (11.76%)  2 1/4 (25.00%)  1 1/4 (25.00%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Constipation  1  0/17 (0.00%)  0 1/17 (5.88%)  3 0/4 (0.00%)  0 1/4 (25.00%)  1 0/15 (0.00%)  0 2/15 (13.33%)  2 0/5 (0.00%)  0 1/6 (16.67%)  1
Diarrhoea  1  0/17 (0.00%)  0 1/17 (5.88%)  1 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
Duodenal ulcer  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Dyspepsia  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
Flatulence  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Nausea  1  0/17 (0.00%)  0 4/17 (23.53%)  5 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
Retroperitoneal haemorrhage  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Vomiting  1  1/17 (5.88%)  1 4/17 (23.53%)  5 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
General disorders                 
Asthenia  1  0/17 (0.00%)  0 3/17 (17.65%)  5 1/4 (25.00%)  1 1/4 (25.00%)  1 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Catheter site oedema  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Chest discomfort  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Chest pain  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Chills  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/4 (25.00%)  2 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Device leakage  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Fatigue  1  0/17 (0.00%)  0 0/17 (0.00%)  0 2/4 (50.00%)  2 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Infusion site haemorrhage  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
Infusion site pain  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Malaise  1  0/17 (0.00%)  0 1/17 (5.88%)  1 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Medical device complication  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Oedema  1  0/17 (0.00%)  0 1/17 (5.88%)  6 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
Oedema peripheral  1  2/17 (11.76%)  2 3/17 (17.65%)  3 0/4 (0.00%)  0 1/4 (25.00%)  1 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Pyrexia  1  1/17 (5.88%)  1 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Tenderness  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
Thrombosis in device  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Hepatobiliary disorders                 
Hepatotoxicity  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Immune system disorders                 
Hypersensitivity  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations                 
Cellulitis  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Chest wall abscess  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Endocarditis  1  2/17 (11.76%)  2 1/17 (5.88%)  1 0/4 (0.00%)  0 1/4 (25.00%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Fungal infection  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Fungal skin infection  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Localised infection  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Osteomyelitis  1  0/17 (0.00%)  0 0/17 (0.00%)  0 2/4 (50.00%)  2 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Osteomyelitis acute  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Septic shock  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Staphylococcal infection  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Urinary tract infection  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0
Injury, poisoning and procedural complications                 
Arteriovenous fistula site complication  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Procedural pain  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Seroma  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
Therapeutic agent toxicity  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
Investigations                 
Blood creatine phosphokinase increased  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Blood glucose decreased  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Blood glucose increased  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  2
Cardiac murmur  1  2/17 (11.76%)  2 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Haemoglobin decreased  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Heart sounds abnormal  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
International normalised ratio increased  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Urine output decreased  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
White blood cell count increased  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders                 
Decreased appetite  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Fluid overload  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Hyperkalaemia  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Hypokalaemia  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
Hypomagnesaemia  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Hyponatraemia  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
Back pain  1  2/17 (11.76%)  3 3/17 (17.65%)  4 0/4 (0.00%)  0 1/4 (25.00%)  2 0/15 (0.00%)  0 1/15 (6.67%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
Flank pain  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Muscle spasms  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal discomfort  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal pain  1  0/17 (0.00%)  0 3/17 (17.65%)  3 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Myalgia  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Neck pain  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Pain in extremity  1  1/17 (5.88%)  1 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders                 
Dizziness  1  0/17 (0.00%)  0 2/17 (11.76%)  2 1/4 (25.00%)  1 0/4 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Dysgeusia  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/5 (20.00%)  1 1/6 (16.67%)  1
Headache  1  0/17 (0.00%)  0 2/17 (11.76%)  4 1/4 (25.00%)  2 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Hypoaesthesia  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
Psychiatric disorders                 
Agitation  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Anxiety  1  0/17 (0.00%)  0 1/17 (5.88%)  2 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Depression  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0
Insomnia  1  0/17 (0.00%)  0 2/17 (11.76%)  2 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Renal and urinary disorders                 
Renal pain  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Cough  1  1/17 (5.88%)  1 1/17 (5.88%)  1 1/4 (25.00%)  1 1/4 (25.00%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Dyspnoea  1  1/17 (5.88%)  1 2/17 (11.76%)  2 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Haemoptysis  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Hiccups  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Rhinorrhoea  1  0/17 (0.00%)  0 1/17 (5.88%)  1 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders                 
Blister  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Dry skin  1  0/17 (0.00%)  0 0/17 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Hyperhidrosis  1  0/17 (0.00%)  0 2/17 (11.76%)  2 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Night sweats  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/4 (25.00%)  2 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Pruritus  1  0/17 (0.00%)  0 3/17 (17.65%)  3 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
Pruritus generalised  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Skin chapped  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Skin disorder  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Skin lesion  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders                 
Deep vein thrombosis  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Hypotension  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first publication is initiated by Cubist. If first publication not published within 1 year of study conclusion or termination, Investigator has right to publish and disclose the data. Prior to any submission for publication, presentation, or communication of results or information arising from the study, Investigator shall provide Cubist at least 90 days for review and comment upon the manuscript or other material for such publication or presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President, Clinical Research
Organization: Cubist Pharmaceuticals, Inc.
Phone: 1.781.860.8660
Layout table for additonal information
Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01104662     History of Changes
Other Study ID Numbers: 3009-022
DAP-RENSE-08-05 ( Other Identifier: Cubist Study Number )
First Submitted: April 2, 2010
First Posted: April 15, 2010
Results First Submitted: April 28, 2015
Results First Posted: May 13, 2015
Last Update Posted: September 5, 2018