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| Sponsor: | Cubist Pharmaceuticals |
|---|---|
| Information provided by (Responsible Party): | Cubist Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00711802 |
Purpose
This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy and pharmacokinetics of daptomycin in pediatric subjects ages 2-17 years, inclusive, with cSSSI caused by Gram-positive pathogens.
| Condition | Intervention | Phase |
|---|---|---|
|
Skin Diseases, Infectious |
Drug: Daptomycin Drug: Vancomycin, Clindamycin or semi-synthetic Penicillins |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | An Evaluation of the Safety, Efficacy and Pharmacokinetics of Daptomycin in Pediatric Subjects Aged Two to Seventeen Years With Complicated Skin and Skin Structure Infections Caused by Gram-Positive Pathogens |
| Estimated Enrollment: | 339 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Daptomycin |
Drug: Daptomycin
i.v. daptomycin given at 5 mg/kg (ages 12-17 years); at 7 mg/kg (ages 7-11 years); or 9 mg/kg (ages 2-6 years)
Other Name: Cubicin
|
|
Active Comparator: Comparator
Comparator recommended as vancomycin, clindamycin or semi-synthetic penicillin administered per standard of care
|
Drug: Vancomycin, Clindamycin or semi-synthetic Penicillins
administered per Standard of Care
|
This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy and pharmacokinetics of daptomycin in pediatric subjects ages 2-17 years, inclusive, with cSSSI caused by Gram-positive pathogens. Subjects will be enrolled into two age groups and given age dependant doses over a period of up to 14 days. Subjects will be stratified by age group to receive either daptomycin or standard of care (recommended as vancomycin, clindamycin or semi-synthetic penicillin) in a ratio of 2:1, respectively. Subjects may continue on oral therapy following completion of i.v. study drug administration and provided that the subject meets all criteria for conversion to oral therapy including clear clinical improvement and availability of an oral agent to which the pathogen is susceptible. The choice of oral therapy will be left to the discretion of the Investigator.
Eligibility| Ages Eligible for Study: | 1 Year to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Claudia Abbes | 781-860-8201 | claudia.abbes@cubist.com |
Show 41 Study Locations| Study Director: | Hernando Patino, MD | Cubist Pharmaceuticals |
More Information
| Responsible Party: | Cubist Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00711802 History of Changes |
| Other Study ID Numbers: | DAP-PEDS-07-03 |
| Study First Received: | July 7, 2008 |
| Last Updated: | February 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Complicated Skin Structure |
|
Communicable Diseases Infection Skin Diseases Skin Diseases, Infectious Clindamycin Clindamycin-2-phosphate Vancomycin Daptomycin |
Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses |