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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2009

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 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.

Intervention(s) in this Clinical Trial

• Drug: Daptomycin
  • i.v. daptomycin given at 5 mg/kg (ages 12-17 years) or at 7 mg/kg (ages 7-11 years)
• Drug: Vancomycin, Clindamycin or semi-synthetic Penicillins
  • administered per Standard of Care

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Daptomycin
• Active Comparator: Comparator
  • Comparator recommended as vancomycin, clindamycin or semi-synthetic penicillin administered per standard of care

Primary Measures

• Safety of daptomycin
  • Time Frame: First dose through end of study
    Safety Issue?: No

Secondary Measures

• Efficacy of daptomycin
  • Time Frame: End of Therapy and Test-of-Cure Visits
    Safety Issue?: No
• Pharmacokinetics of daptomycin
  • Time Frame: Day 3 (5 timepoints)
    Safety Issue?: No

Inclusion Criteria:

• Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care;
• Written subject assent (as appropriate);
• Male or female between the ages of 7 and 17 years old, inclusive;
• If female of childbearing potential (defined as post-menarche), not lactating or pregnant, documented negative pregnancy test result within 48 hours prior to study medication administration and willing to practice reliable birth control measures (at the discretion of the Principal Investigator) during study treatment and for at least 28 days after study completion;
• Able to comply with the protocol for the duration of the study;
• Skin and skin structure infections of a complicated nature known or suspected to be caused by Gram-positive pathogen(s) that require intravenous antibiotic treatment.
• Complicated infections are defined as infections either involving deep soft tissue or requiring significant surgical intervention (e.g. infected ulcers, burns, and major abscesses) or infections in which the subject has a significant underlying disease state that complicates the response to treatment. The Investigator may contact the Medical Monitor to discuss infections not meeting this definition but which otherwise appear appropriate for inclusion;
• At least three of the following clinical signs and symptoms associated with the cSSSI: pain;tenderness to palpation;temperature >37.5 degrees C (99.5 degrees F) oral or >38 degrees C (100.4 degrees F) rectal; white blood count (WBC) >12,000/mm3 or ≥10% bands;
• swelling and/or induration;erythema (>1 cm beyond edge of wound or abscess); pus formation

Exclusion Criteria:

• Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry;
• Known allergy/ hypersensitivity to daptomycin;
• Known infection caused solely by Gram-negative pathogen(s), fungus(i) or virus(es);
• Previous systemic antimicrobial therapy exceeding 24 hours duration administered anytime during the 48 hours prior to the first dose of study drug (exception: a subject is eligible if on previous antibiotics without any clinical improvement and/or a wound culture is available and the pathogen is not sensitive to prior therapy);
• Known or suspected pneumonia, osteomyelitis, meningitis or endocarditis;
• Known bacteremia (exception: any subject enrolled in the study that is subsequently found to have a blood culture positive for bacteremia may be continued as described in section 10.4.4);
• Subjects with current or known clinically significant abnormal laboratory test results (including ECGs) that would expose the subject to unacceptable risk as determined by Investigator;
• History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematological, autoimmune disease or primary immune deficiency [unless the Investigator considers that the subject would not be at risk by participating in the study (Note: HIV infected subjects must not be enrolled)];
• History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system or seizure disorder;
• Unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barre or spinal cord injury;
• Administration of intramuscular injection between baseline and study drug administration or expected intramuscular injection through TOC/Safety visit;
• Suspected or known renal insufficiency;
• History of or current rhabdomyolysis;
• History of (within one year prior to first dose of study drug) or current myositis;
• Current septic shock;
• Known or suspected CPK elevation

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 7 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Cubist Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Peter Pertel, MD Study Director Cubist Pharmaceuticals  

Overall Contact: Andrea Clarke 781-860-8660 andrea.clarke@cubist.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00711802

Study ID Number: DAP-PEDS-07-03

ClinicalTrials.gov Identifier: NCT00711802

Health Authority: United States: Food and Drug Administration