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NCT01104662 · ClinicalTrials.gov registry record · Phase 4
Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment
A Phase 4 study, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Terminated
- Registry status
- Phase 4
- Development phase
- 92
- Enrollment target
NCT01104662 is a Phase 4 study that was terminated before completion, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 92 participants.
The verdict
NCT01104662, a Phase 4 study, was terminated before completion, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 92 participants
- Enrollment target
Study 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.
Interventions
- DRUG Vancomycin
- DRUG Daptomycin
- DRUG Semi-Synthetic Penicillin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2010-04-19 |
| Est. Completion | 2012-06-12 |
| Phase | Phase 4 |
Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)42 total trials
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01104662
The ClinicalTrials.gov registry entry for NCT01104662 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 42 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Vancomycin is the first listed.
NCT01104662 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01104662 about?
NCT01104662 is a clinical study titled "Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment". 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 ...
What is the current status of trial NCT01104662?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 92 participants. The study started on 2010-04-19. Estimated completion is 2012-06-12.
What interventions are being tested in trial NCT01104662?
The interventions under investigation include: Vancomycin (DRUG), Daptomycin (DRUG), Semi-Synthetic Penicillin (DRUG).
Who is sponsoring clinical trial NCT01104662?
This trial is sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 42 total clinical trials registered on ClinicalTrials.gov.
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