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Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA (DAPHEOR1006)

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ClinicalTrials.gov Identifier: NCT01419184
Recruitment Status : Completed
First Posted : August 18, 2011
Results First Posted : July 8, 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: None (Open Label);   Primary Purpose: Treatment
Condition Staphylococcal Skin Infections
Interventions Drug: Daptomycin
Drug: Vancomycin
Enrollment 250
Recruitment Details  
Pre-assignment Details One participant enrolled in the study but was lost to follow up prior to being randomized to either treatment arm (daptomycin or vancomycin). This participant did not receive study drug and was not included in further analysis. No further details are available for this participant.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for complicated skin and skin structure infections (cSSSI) or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion. Vancomycin was reconstituted per the manufacturer’s instructions and was dosed per investigator’s discretion and was administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occured first. Investigators treated participants according to their usual decision-making and discretion.
Period Title: Overall Study
Started 128 121
Received at Least 1 Dose of Study Drug 118 106
Completed 118 [1] 106 [2]
Not Completed 10 15
Reason Not Completed
Site data not available             3             2
No IRLOS-No in-patient end date reported             3             6
No IRLOS-randomized, not treated             2             4
No IRLOS-non trial antibiotic used             1             2
No IRLOS-No adverse event treatment date             0             1
Participant randomized, not treated             1             0
[1]
6 participants did not complete the study due to no valid infection-related length of stay (IRLOS)
[2]
13 participants did not complete the study due to no valid infection-related length of stay (IRLOS)
Arm/Group Title Daptomycin Vancomycin Total
Hide Arm/Group Description Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day 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. Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously 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 118 106 224
Hide Baseline Analysis Population Description
Baseline analysis population is drawn from the subset of the entire sample of participants that received at least 1 dose of study drug and that had complete data for calculating the primary outcome, infection-related length of stay (IRLOS).
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 118 participants 106 participants 224 participants
18-29 Years Old 16 10 26
30-39 Years Old 22 17 39
40-49 Years Old 30 21 51
50-59 Years Old 26 32 58
60-69 Years Old 14 21 35
70+ Years Old 10 5 15
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants 106 participants 224 participants
Female
54
  45.8%
49
  46.2%
103
  46.0%
Male
64
  54.2%
57
  53.8%
121
  54.0%
1.Primary Outcome
Title Infection-Related Hospital Length of Stay
Hide Description Infection Related Hospital Length of Stay (IRLOS) is defined as the number of hours of hospitalization associated with antibiotic treatment of the complicated skin and skin structure infections (cSSSI) beginning at initiation of study-antibiotic administration and ending at discontinuation of all antibiotic therapy for cSSSI or at hospital discharge (whichever occurred first). This included continued hospitalization for treatment of adverse events resulting from use of the study antibiotic or subsequent antimicrobial therapy. The mean number of hours for each treatment group is presented.
Time Frame Baseline (Day 0) through the End of Hospital Stay (up to Day 14)
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. As the end of the IRLOS depended upon the participant’s course of treatment, no static set of items were answered to determine if a participant had complete data.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day 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.
Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously 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 118 106
Mean (Standard Deviation)
Unit of Measure: Hours
91.46  (57.81) 93.23  (60.78)
2.Secondary Outcome
Title Mean Change From Baseline to Hospital Discharge in Pain According to the Brief Pain Inventory-Short Form (BPI-SF)
Hide Description Pain was measured as the amount of pain experienced “right now” by the participant using an 11-point numerical rating scale adapted from Brief Pain Inventory-Short Form (BPI-SF). Participants were asked to rate pain in his or her skin infection from 0 to 10, where 0 is no pain and 10 is pain as bad as he or she could imagine. Change from baseline to hospital discharge is presented; a negative value represents a decrease in pain.
Time Frame Baseline (Day 0), End of Hospital Stay (up to Day 14)
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable BPI-SF data at baseline and at hospital discharge.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day 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.
Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously 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 105 98
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.08  (3.13) -2.54  (3.46)
3.Secondary Outcome
Title Mean Change From Baseline to Hospital Discharge in Participant-reported Health-related Quality of Life (HRQoL)
Hide Description Health-related quality of life (HRQoL) was measured using the EuroQol-5 Dimensions, 5 Level (EQ-5D-5L) multi-attribute questionnaire. The 5 dimensions measured were: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant's health state was expressed by a descriptive profile of a 5 digit number. The EQ-5D health states were converted into a single summary index (from 0 to 1, with 0 representing death, to 1 representing perfect health) by applying weights to each of the levels in each dimension. Change from baseline to hospital discharge is presented; positive values represent an increase in health utility.
Time Frame Baseline (Day 0), End of Hospital Stay (up to Day 14)
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable EQ-5D data at baseline and at hospital discharge.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day 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.
Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously 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 105 98
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.12  (0.20) 0.18  (0.21)
4.Secondary Outcome
Title Participant Global Impression of Improvement (PGI-I) at Hospital Discharge
Hide Description PGI-I assessments of improvement were measured by asking participants: How is your skin infection today compared to how it was yesterday? Scores were calculated based on response to the single item, where 1 = improved a lot; 2 = improved moderately; 3 = improved a little; 4 = no change; 5 = worsened a little; 6 = worsened moderately; 7 = worsened a lot. Mean PGI-I scores are presented at hospital discharge; lower values represent greater improvement.
Time Frame End of Hospital Stay (up to Day 14)
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable PGI-I data at hospital discharge.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day 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.
Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously 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 102 97
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.05  (1.16) 1.80  (0.94)
5.Secondary Outcome
Title 30-day cSSSI-related Hospital Readmission Rates
Hide Description Hospital readmission rates were defined as readmission to an inpatient hospital facility within 30 days of hospital discharge for management of cSSSI relapse or treatment of adverse events related to cSSSI treatment. It did not include all-cause readmissions (for completeness, all-cause readmissions are reported in the descriptive tables). Participants were asked if they had been readmitted to the hospital since their discharge and whether the admission was specifically for their skin infection. The number of participants who were re-hospitalized for skin infection or side effects due to skin infection medication within 30 days since the initial hospital discharge (Day 14) is presented.
Time Frame End of Hospital Stay (up to Day 14) through 30 days post hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day 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.
Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously 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 118 106
Measure Type: Number
Unit of Measure: participants
5 2
6.Secondary Outcome
Title cSSSI-related Medical Resource Utilization and Costs
Hide Description Direct medical costs were based on utilization of health resources. Unit cost data were obtained from sources external to the trial and assigned to corresponding medical resource utilization observed within the trial to estimate costs of care. cSSSI-related costs were reported from a societal perspective, and further broken down into a health care system perspective. The health care system perspective includes hospital and outpatient costs. The societal perspective includes the health care system perspective plus participant and caregiver time loss from work and participant and caregiver out-of-pocket expenses. Total cost (including both total inpatient and total post-discharge costs) per participant is presented.
Time Frame Baseline (Day 0) through 30 days post hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day 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.
Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously 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 118 106
Mean (Standard Deviation)
Unit of Measure: dollars (United States)
Health Care System Perspective 10441.30  (7952.40) 9894.34  (6620.51)
Societal Perspective 11085.57  (8120.20) 10397.24  (6827.55)
Time Frame [Not Specified]
Adverse Event Reporting Description Only serious adverse events were collected for this study.
 
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day 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. Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously 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 Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Daptomycin Vancomycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/118 (12.71%)      9/106 (8.49%)    
Blood and lymphatic system disorders     
Atrial Fibrillation   0/118 (0.00%)  0 1/106 (0.94%)  1
Cardiac disorders     
cardiac arrest   1/118 (0.85%)  1 0/106 (0.00%)  0
Sinus bradycardia   1/118 (0.85%)  1 0/106 (0.00%)  0
General disorders     
Lyme infection, Lyme disease   1/118 (0.85%)  1 0/106 (0.00%)  0
Immune system disorders     
Allergic reaction (dermatologic)   0/118 (0.00%)  0 1/106 (0.94%)  1
Infections and infestations     
Osteomyelitis, Foot   0/118 (0.00%)  0 1/106 (0.94%)  1
Worsening infection to left hand due to non-compliance   1/118 (0.85%)  1 0/106 (0.00%)  0
Right prepatella bursitis with abscess, Bursitis infective   1/118 (0.85%)  1 0/106 (0.00%)  0
Acute Viral Syndrome   0/118 (0.00%)  0 1/106 (0.94%)  1
Bilat Lower Extrem Cellulitis, Cellulitis of legs   1/118 (0.85%)  1 0/106 (0.00%)  0
Chest Wall infection status post right breast implant removal   1/54 (1.85%)  1 0/49 (0.00%)  0
Clinical worsening of right below knee stump infection   0/118 (0.00%)  0 1/106 (0.94%)  1
Left hallux osteomyelitis   0/118 (0.00%)  0 1/106 (0.94%)  1
Osteomyelitis   1/118 (0.85%)  1 0/106 (0.00%)  0
Osteomyelitis with septic arthritis   1/118 (0.85%)  1 0/106 (0.00%)  0
Pneumonia   2/118 (1.69%)  2 0/106 (0.00%)  0
Right Leg Cellulitis   0/118 (0.00%)  0 1/106 (0.94%)  1
Nervous system disorders     
Seizure   1/118 (0.85%)  1 0/106 (0.00%)  0
Psychiatric disorders     
altered mental status   0/118 (0.00%)  0 1/106 (0.94%)  1
Renal and urinary disorders     
respiratory failure   0/118 (0.00%)  0 1/106 (0.94%)  1
Renal insufficiency   1/118 (0.85%)  1 0/106 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Shortness of breath   1/118 (0.85%)  1 0/106 (0.00%)  0
Skin and subcutaneous tissue disorders     
red man syndrome   1/118 (0.85%)  1 0/106 (0.00%)  0
Social circumstances     
social admission for reassignment of nursing home   1/118 (0.85%)  1 0/106 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Daptomycin Vancomycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
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.
 
Results Point of Contact
Name/Title: Vice President, Clinical Research
Organization: Cubist Pharmaceuticals
Phone: 1.781.860.8660
Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01419184     History of Changes
Other Study ID Numbers: 3009-015
DAP-HEOR-10-06 ( Other Identifier: Cubist Study Number )
First Submitted: August 16, 2011
First Posted: August 18, 2011
Results First Submitted: April 23, 2015
Results First Posted: July 8, 2015
Last Update Posted: September 5, 2018