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
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Soft Tissue Infections | Drug: daptomycin (up to 14 days) | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 72 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | January 2005 |
| Actual Primary Completion Date : | November 2006 |
| Actual Study Completion Date : | November 2006 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Daptomycin
Primary Outcome Measures :
- To obtain additional pharmacokinetic data (on dosing days) on intravenous daptomycin in patients with complicated skin and skin structure infections and renal impairment
Secondary Outcome Measures :
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102947
Locations
| United States, California | |
| Harbor UCLA Medical Center | |
| Torrance, California, United States, 90509 | |
| United States, Florida | |
| Tampa General Hospital | |
| Tampa, Florida, United States, 33606 | |
| United States, Georgia | |
| Joseph M. Still Research Institute | |
| Augusta, Georgia, United States | |
| United States, Minnesota | |
| Infectious Diseases Minneapolis-LTD | |
| Minneapolis, Minnesota, United States, 55422 | |
| United States, New York | |
| Upstate Clinical Research Associates | |
| Buffalo, New York, United States, 14203 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| AllTrials Clinical Research | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Riverside Methodist Hospital | |
| Columbus, Ohio, United States, 43215 | |
| Wright State University/Veterans Affairs Medical Center | |
| Dayton, Ohio, United States, 45428 | |
| ID Clinical Research | |
| Toledo, Ohio, United States, 43608 | |
| United States, Pennsylvania | |
| St. Luke's Hospital | |
| Bethlehem, Pennsylvania, United States, 19015 | |
| The Reading Hospital and Medical Center | |
| West Reading, Pennsylvania, United States, 19610 | |
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
| Responsible Party: | Cubist Pharmaceuticals LLC |
| ClinicalTrials.gov Identifier: | NCT00102947 |
| Other Study ID Numbers: |
3009-020 DAP-REN-03-06 ( Other Identifier: Cubist Study Number ) |
| First Posted: | February 7, 2005 Key Record Dates |
| Last Update Posted: | July 25, 2016 |
| Last Verified: | July 2016 |
Keywords provided by Cubist Pharmaceuticals LLC:
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renal impairment daptomycin Cubist complicated skin and skin structure infections |
Additional relevant MeSH terms:
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Infections Communicable Diseases Soft Tissue Infections Skin Diseases, Bacterial Disease Attributes Pathologic Processes Bacterial Infections |
Bacterial Infections and Mycoses Skin Diseases, Infectious Skin Diseases Daptomycin Anti-Bacterial Agents Anti-Infective Agents |