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Sponsored by: |
Cubist Pharmaceuticals |
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Information provided by: | Cubist Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00711802 |
This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy and pharmacokinetics of daptomycin in pediatric subjects ages 7-17 years, inclusive, with cSSSI caused by Gram-positive pathogens.
Condition | Intervention | Phase |
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Skin Diseases, Infectious |
Drug: Daptomycin Drug: Vancomycin, Clindamycin or semi-synthetic Penicillins |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Evaluation of the Safety, Efficacy and Pharmacokinetics of Daptomycin in Pediatric Subjects Aged Seven to Seventeen Years With Complicated Skin and Skin Structure Infections Caused by Gram-Positive Pathogens |
Estimated Enrollment: | 225 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Daptomycin: Experimental |
Drug: Daptomycin
i.v. daptomycin given at 5 mg/kg (ages 12-17 years) or at 7 mg/kg (ages 7-11 years)
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Comparator: Active Comparator
Comparator recommended as vancomycin, clindamycin or semi-synthetic penicillin administered per standard of care
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Drug: Vancomycin, Clindamycin or semi-synthetic Penicillins
administered per Standard of Care
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This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy and pharmacokinetics of daptomycin in pediatric subjects ages 7-17 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.
Ages Eligible for Study: | 7 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrea Clarke | 781-860-8660 ext 8458 | andrea.clarke@cubist.com |
United States, California | |
Rady Children's Hospital - San Diego | Recruiting |
San Diego, California, United States, 92123 | |
United States, Florida | |
Lee Memorial Health System | Recruiting |
Fort Myers, Florida, United States, 33908 | |
United States, Nebraska | |
University of Nebraska Medical Center | Recruiting |
Omaha, Nebraska, United States, 68198 | |
Contact: Kari Simonsen, MD 402-559-8883 kasimonsen@unmc.edu | |
Principal Investigator: Kari Simonsen, MD | |
United States, Ohio | |
Nationwide Children's Hospital | Recruiting |
Columbus, Ohio, United States, 43205 | |
University Hospitals Case Medical Center | Recruiting |
Cleveland, Ohio, United States, 44106 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Withdrawn |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Tennessee | |
LeBonheur Children's Medical Center | Recruiting |
Memphis, Tennessee, United States, 38105 |
Study Director: | Peter Pertel, MD | Cubist Pharmaceuticals |
Responsible Party: | Cubist Pharmaceuticals, Inc. ( Ed Campanaro/Vice President, Clinical Operations ) |
Study ID Numbers: | DAP-PEDS-07-03 |
Study First Received: | July 7, 2008 |
Last Updated: | April 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00711802 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Complicated Skin Structure |
Daptomycin Anti-Bacterial Agents Clindamycin Skin Diseases, Infectious |
Clindamycin-2-phosphate Skin Diseases Vancomycin |
Communicable Diseases Anti-Infective Agents Clindamycin Skin Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Pharmacologic Actions Daptomycin Protein Synthesis Inhibitors Anti-Bacterial Agents Skin Diseases, Infectious Therapeutic Uses |