Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 4 study, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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
Why NCT01104662 stopped before completion
NCT01104662 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which Vancomycin is the first listed.
NCT01104662 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01104662's enrollment target sits among peer trials
92 876th of 2000 higher than 1,117 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03184545 · 92 participants · Phase 3
Comparing the Outcome of Electrical Stimulation and Physical Therapy in Patellofemoral Pain Syndrome
- NCT04172532 · 92 participants · Phase 1
Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
- NCT04508088 · 92 participants
Skeletal Health and Bone Marrow Composition in Newly Diagnosed Adolescents With Crohn Disease
- NCT04840602 · 92 participants · Phase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI