Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections
This study has been terminated.
Sponsor:
Cubist Pharmaceuticals
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00102947
First received: February 4, 2005
Last updated: May 21, 2007
Last verified: May 2007
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Soft Tissue Infections |
Drug: daptomycin (up to 14 days) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Cubist Pharmaceuticals:
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
| Estimated Enrollment: | 72 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | May 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00102947 History of Changes |
| Other Study ID Numbers: | DAP-REN-03-06 |
| Study First Received: | February 4, 2005 |
| Last Updated: | May 21, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cubist Pharmaceuticals:
|
renal impairment daptomycin Cubist complicated skin and skin structure infections |
Additional relevant MeSH terms:
|
Renal Insufficiency Soft Tissue Infections Kidney Diseases Urologic Diseases Infection |
Daptomycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013