Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections
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| ClinicalTrials.gov Identifier: NCT00102947 |
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Recruitment Status :
Terminated
First Posted : February 7, 2005
Last Update Posted : July 25, 2016
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Sponsor:
Cubist Pharmaceuticals LLC
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date ICMJE | February 4, 2005 | ||
| First Posted Date ICMJE | February 7, 2005 | ||
| Last Update Posted Date | July 25, 2016 | ||
| Study Start Date ICMJE | January 2005 | ||
| Actual Primary Completion Date | November 2006 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
To obtain additional pharmacokinetic data (on dosing days) on intravenous daptomycin in patients with complicated skin and skin structure infections and renal impairment | ||
| Original Primary Outcome Measures ICMJE | Same as current | ||
| Change History | |||
| Current Secondary Outcome Measures ICMJE |
To compare the safety and efficacy of daptomycin to comparator in patients with complicated skin and skin structure infections and renal impairment at 14 to 21 days after last dose | ||
| Original Secondary Outcome Measures ICMJE | Same as current | ||
| Current Other Pre-specified Outcome Measures | Not Provided | ||
| Original Other Pre-specified Outcome Measures | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections | ||
| Official Title ICMJE | An Open Label Phase 4 Trial to Further Evaluate the Pharmacokinetic Profile of Intravenous Daptomycin, and a Comparison of the Safety and Efficacy of Daptomycin Versus Comparator in the Treatment of Adult Patients With Renal Impairment and Complicated Skin and Skin Structure Infections Due, at Least in Part, to Gram-positive Bacteria | ||
| Brief Summary | This is a Phase 4, randomized, open-label, multicenter, comparative study designed to further evaluate the pharmacokinetics of intravenous (i.v.) daptomycin and the safety and efficacy of daptomycin relative to comparator in the treatment of complicated skin and skin structure infections in patients with renal impairment. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 4 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Soft Tissue Infections | ||
| Intervention ICMJE | Drug: daptomycin (up to 14 days) | ||
| Study Arms ICMJE | Not Provided | ||
| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Terminated | ||
| Enrollment ICMJE |
72 | ||
| Original Enrollment ICMJE | Same as current | ||
| Actual Study Completion Date ICMJE | November 2006 | ||
| Actual Primary Completion Date | November 2006 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Moderate to end-stage renal impairment - A diagnosis of complicated skin and skin structure infection known or suspected to be due to susceptible Gram-positive bacteria based on positive Gram stain - A diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor Exclusion Criteria: - Known bacteremia, osteomyelitis or endocarditis | ||
| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00102947 | ||
| Other Study ID Numbers ICMJE | 3009-020 DAP-REN-03-06 ( Other Identifier: Cubist Study Number ) |
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| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Current Responsible Party | Cubist Pharmaceuticals LLC | ||
| Original Responsible Party | Not Provided | ||
| Current Study Sponsor ICMJE | Cubist Pharmaceuticals LLC | ||
| Original Study Sponsor ICMJE | Same as current | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Cubist Pharmaceuticals LLC | ||
| Verification Date | July 2016 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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