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| ID | Type | Description | Link |
|---|---|---|---|
| DAP-REN-03-06 | Other Identifier | Cubist Study Number |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| daptomycin (up to 14 days) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To obtain additional pharmacokinetic data (on dosing days) on intravenous daptomycin in patients with complicated skin and skin structure infections and renal impairment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbor UCLA Medical Center | Torrance | California | 90509 | United States | ||
| Tampa General Hospital |
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| Tampa |
| Florida |
| 33606 |
| United States |
| Joseph M. Still Research Institute | Augusta | Georgia | United States |
| Infectious Diseases Minneapolis-LTD | Minneapolis | Minnesota | 55422 | United States |
| Upstate Clinical Research Associates | Buffalo | New York | 14203 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| AllTrials Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43215 | United States |
| Wright State University/Veterans Affairs Medical Center | Dayton | Ohio | 45428 | United States |
| ID Clinical Research | Toledo | Ohio | 43608 | United States |
| St. Luke's Hospital | Bethlehem | Pennsylvania | 19015 | United States |
| The Reading Hospital and Medical Center | West Reading | Pennsylvania | 19610 | United States |
| ID | Term |
|---|---|
| D018461 | Soft Tissue Infections |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D017576 | Daptomycin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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