Trials / Terminated
TerminatedNCT01104662
Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment
A Prospective, Multicenter, Randomized, Evaluator-blinded, Comparator-controlled Study to Describe the Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin Structure Infections (cSSSI) and Staphylococcus Aureus Bacteremia Among Subjects With Moderate or Severe Renal Impairment
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, randomized, evaluator-blinded, comparator-controlled study. Participants were to be randomized (1:1) to daptomycin or comparator, stratified by degree of renal impairment (creatinine clearance \[CLcr\] 30 - 50 milliliters per minute \[mL/min\] \[moderate impairment\] and \<30 mL/min \[severe impairment\]) and by type of infection (bacteremia and complicated skin and skin structure infections \[cSSSI\]) to create 4 cohorts defined as follows: * Cohort 1: Bacteremia and CLcr \<30 mL/min * Cohort 2: Bacteremia and CLcr 30 - 50 mL/min * Cohort 3: cSSSI and CLcr \<30 mL/min * Cohort 4: cSSSI and CLcr 30 - 50 mL/min Participants will be treated and evaluated for safety and microbiological and clinical efficacy in accordance with their type of infection and degree of renal impairment. Peak and trough samples will be collected to assess exposure to daptomycin for participants on Day 1 and following the 5th dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vancomycin | |
| DRUG | Daptomycin | |
| DRUG | Semi-Synthetic Penicillin |
Timeline
- Start date
- 2010-04-19
- Primary completion
- 2012-06-12
- Completion
- 2012-06-12
- First posted
- 2010-04-15
- Last updated
- 2018-09-05
- Results posted
- 2015-05-13
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01104662. Inclusion in this directory is not an endorsement.