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Trial record 4 of 8 for:    NAFCILLIN AND cloxacillin

A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial

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: NCT02208063
Recruitment Status : Terminated (Halted due to lack of statistical power. No safety concerns identified.)
First Posted : August 4, 2014
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bacteremia
Interventions Drug: Telavancin
Drug: Vancomycin
Drug: Daptomycin
Drug: Synthetic penicillin
Drug: Cefazolin
Enrollment 121
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Telavancin Standard of Care
Hide Arm/Group Description

7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes

Telavancin

Vancomycin, Daptomycin, synthetic penicillin or Cefazolin

Vancomycin

Daptomycin

Synthetic penicillin

Cefazolin

Period Title: Overall Study
Started [1] 60 61
Randomized and Treated 58 60
Microbiological All Treated [2] 47 52
Completed 48 50
Not Completed 12 11
Reason Not Completed
Death             3             5
Not Specified in report             3             4
Withdrawal by Subject             5             2
Lost to Follow-up             1             0
[1]
All Randomized
[2]
Includes all subjects in the AT population who had a mono-microbial QBC positive for S. aureus.
Arm/Group Title Telavancin Standard of Care Total
Hide Arm/Group Description

7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes

Telavancin

Vancomycin, Daptomycin, synthetic penicillin or Cefazolin

Vancomycin

Daptomycin

Synthetic penicillin

Cefazolin

Total of all reporting groups
Overall Number of Baseline Participants 57 60 117
Hide Baseline Analysis Population Description
Demographic (All-Treated Population)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 60 participants 117 participants
52.3  (16.41) 56.5  (16.33) 54.5  (16.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 60 participants 117 participants
Female
18
  31.6%
17
  28.3%
35
  29.9%
Male
39
  68.4%
43
  71.7%
82
  70.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 60 participants 117 participants
Hispanic or Latino
20
  35.1%
19
  31.7%
39
  33.3%
Not Hispanic or Latino
37
  64.9%
41
  68.3%
78
  66.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 60 participants 117 participants
American Indian or Alaska Native
3
   5.3%
3
   5.0%
6
   5.1%
Black or African American
8
  14.0%
5
   8.3%
13
  11.1%
White
44
  77.2%
48
  80.0%
92
  78.6%
Other
2
   3.5%
2
   3.3%
4
   3.4%
Missing
0
   0.0%
1
   1.7%
1
   0.9%
Multiple
0
   0.0%
1
   1.7%
1
   0.9%
1.Primary Outcome
Title Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)
Hide Description

The efficacy endpoint of clinical outcome of cure at the test of cure (TOC) was determined by subjects who meet all of the following criteria, as determined by the investigator and adjudicated by the blinded independent efficacy adjudication committee (IEAC).

  1. Alive at TOC
  2. Resolution of all clinical signed and symptoms of the Staphylococcus aureus (S. aureus) infection at TOC
  3. No evidence of microbiological persistence of relapse
  4. No new foci of metastatic S. aureus infection after Day 8
Time Frame Up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.
Arm/Group Title Telavancin Standard of Care
Hide Arm/Group Description:

7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes

Telavancin

Vancomycin, Daptomycin, synthetic penicillin or Cefazolin

Vancomycin

Daptomycin

Synthetic penicillin

Cefazolin

Overall Number of Participants Analyzed 47 52
Measure Type: Count of Participants
Unit of Measure: Participants
Cure
22
  46.8%
27
  51.9%
Failure
19
  40.4%
21
  40.4%
Indeterminate
6
  12.8%
4
   7.7%
2.Secondary Outcome
Title Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population
Hide Description

The efficacy endpoint of Investigator clinical outcome of cure at the test of cure (TOC) was determined by the following criteria:

  1. Subject alive at TOC
  2. Resolution of all clinical signs and symptoms of the S. aureus infection at TOC (unless explained by a more likely alternative diagnosis)
  3. No evidence of microbiological persistence or relapse
  4. No new foci of metastatic S. aureus infection after Day 8
Time Frame Up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.
Arm/Group Title Telavancin Standard of Care
Hide Arm/Group Description:

7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes

Telavancin

Vancomycin, Daptomycin, synthetic penicillin or Cefazolin

Vancomycin

Daptomycin

Synthetic penicillin

Cefazolin

Overall Number of Participants Analyzed 47 52
Measure Type: Count of Participants
Unit of Measure: Participants
Cure
26
  55.3%
31
  59.6%
Failure
15
  31.9%
19
  36.5%
Indeterminate
3
   6.4%
0
   0.0%
Missing
3
   6.4%
2
   3.8%
3.Secondary Outcome
Title Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population
Hide Description This efficacy endpoint was determined to be a clinical failure if the subject switched study antibiotic due to lack of clinical response
Time Frame Up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.
Arm/Group Title Telavancin Standard of Care
Hide Arm/Group Description:

7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes

Telavancin

Vancomycin, Daptomycin, synthetic penicillin or Cefazolin

Vancomycin

Daptomycin

Synthetic penicillin

Cefazolin

Overall Number of Participants Analyzed 47 52
Measure Type: Count of Participants
Unit of Measure: Participants
Success
28
  59.6%
36
  69.2%
Failure
13
  27.7%
15
  28.8%
Indeterminate
5
  10.6%
0
   0.0%
Missing
1
   2.1%
1
   1.9%
4.Secondary Outcome
Title Number of Participants With the Development of a New Metastatic Foci of S. Aureus Infection at Test of Cure (TOC) in the Microbiological All-treated (mAT) Populations
Hide Description After Day 8, any sign or symptom leading to a subsequent confirmed diagnosis of a new metastatic foci of S. aureus infection
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.
Arm/Group Title Telavancin Standard of Care
Hide Arm/Group Description:

7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes

Telavancin

Vancomycin, Daptomycin, synthetic penicillin or Cefazolin

Vancomycin

Daptomycin

Synthetic penicillin

Cefazolin

Overall Number of Participants Analyzed 47 52
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
6
  12.8%
3
   5.8%
No
32
  68.1%
41
  78.8%
Indeterminate
9
  19.1%
8
  15.4%
Time Frame 38 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Telavancin Standard of Care
Hide Arm/Group Description

7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes

Telavancin

Vancomycin, Daptomycin, synthetic penicillin or Cefazolin

Vancomycin

Daptomycin

Synthetic penicillin

Cefazolin

All-Cause Mortality
Telavancin Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   3/58 (5.17%)      5/60 (8.33%)    
Hide Serious Adverse Events
Telavancin Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/58 (27.59%)      13/60 (21.67%)    
Blood and lymphatic system disorders     
Anaemia * 1  0/58 (0.00%)  0 1/60 (1.67%)  1
Cardiac disorders     
Cardiac failure * 1  0/58 (0.00%)  0 1/60 (1.67%)  1
Cardiovascular insufficiency * 1  1/58 (1.72%)  1 0/60 (0.00%)  0
General disorders     
Multi-organ failure * 1  1/58 (1.72%)  1 1/60 (1.67%)  1
Non-cardiac chest pain * 1  1/58 (1.72%)  1 0/60 (0.00%)  0
Pyrexia * 1  1/58 (1.72%)  1 0/60 (0.00%)  0
Unintentional medical device removal * 1  0/58 (0.00%)  0 1/60 (1.67%)  1
Infections and infestations     
Bacteraemia * 1  0/58 (0.00%)  0 2/60 (3.33%)  2
Osteomyelitis * 1  2/58 (3.45%)  2 0/60 (0.00%)  0
Sepsis * 1  1/58 (1.72%)  1 1/60 (1.67%)  1
Arthritis bacterial * 1  0/58 (0.00%)  0 1/60 (1.67%)  1
Cellulitis * 1  1/58 (1.72%)  1 0/60 (0.00%)  0
Escherichia bacteraemia * 1  0/58 (0.00%)  0 1/60 (1.67%)  1
Extradural abscess * 1  0/58 (0.00%)  0 1/60 (1.67%)  1
Pneumonia * 1  0/58 (0.00%)  0 1/60 (1.67%)  1
Septic shock * 1  1/58 (1.72%)  1 0/60 (0.00%)  0
Serratia infection * 1  1/58 (1.72%)  1 0/60 (0.00%)  0
Spinal empyema * 1  1/58 (1.72%)  1 0/60 (0.00%)  0
Investigations     
Blood creatinine increased * 1  1/58 (1.72%)  1 0/60 (0.00%)  0
Electrocardiogram QT prolonged * 1  1/58 (1.72%)  1 0/60 (0.00%)  0
Hepatic enzyme increased * 1  0/58 (0.00%)  0 1/60 (1.67%)  1
Liver function test abnormal * 1  1/58 (1.72%)  1 0/60 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion * 1  0/58 (0.00%)  0 1/60 (1.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant peritoneal neoplasm * 1  0/58 (0.00%)  0 1/60 (1.67%)  1
Nervous system disorders     
Brain oedema * 1  1/58 (1.72%)  1 0/60 (0.00%)  0
Encephalopathy * 1  0/58 (0.00%)  0 1/60 (1.67%)  1
Renal and urinary disorders     
Acute kidney injury * 1  1/58 (1.72%)  1 2/60 (3.33%)  2
Tubulointerstitial nephritis * 1  0/58 (0.00%)  0 1/60 (1.67%)  1
Urinary retention * 1  0/58 (0.00%)  0 1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  1/58 (1.72%)  1 0/60 (0.00%)  0
Respiratory failure * 1  1/58 (1.72%)  1 0/60 (0.00%)  0
Vascular disorders     
Haematoma * 1  0/58 (0.00%)  0 1/60 (1.67%)  1
Shock * 1  0/58 (0.00%)  0 1/60 (1.67%)  1
1
Term from vocabulary, MedDRA®; version 18
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telavancin Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/58 (50.00%)      25/60 (41.67%)    
Blood and lymphatic system disorders     
Anaemia * 1  6/58 (10.34%)  6 7/60 (11.67%)  7
Gastrointestinal disorders     
Nausea * 1  6/58 (10.34%)  6 6/60 (10.00%)  6
Constipation * 1  3/58 (5.17%)  3 7/60 (11.67%)  7
Diarrhoea * 1  3/58 (5.17%)  3 6/60 (10.00%)  6
Metabolism and nutrition disorders     
Hypokalaemia * 1  10/58 (17.24%)  10 8/60 (13.33%)  8
Nervous system disorders     
Headache * 1  3/58 (5.17%)  3 3/60 (5.00%)  3
Psychiatric disorders     
Insomnia * 1  5/58 (8.62%)  5 3/60 (5.00%)  3
Renal and urinary disorders     
Acute kidney injury * 1  4/58 (6.90%)  4 8/60 (13.33%)  8
1
Term from vocabulary, MedDRA®; version 18
*
Indicates events were collected by non-systematic assessment
At the interim analysis, study was deemed to be inadequately powered & terminated prematurely.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Senior Director of Clinical and Regulatory Affairs
Organization: Cumberland Pharmaceuticals Inc.
Phone: 615-255-0068
EMail: ahaeberle@cumberlandpharma.com
Layout table for additonal information
Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02208063    
Other Study ID Numbers: 0112
First Submitted: July 31, 2014
First Posted: August 4, 2014
Results First Submitted: October 16, 2019
Results First Posted: February 17, 2020
Last Update Posted: February 17, 2020