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Safety and Efficacy Study of Daptomycin in Pediatric Subjects (7-17 Years)With Skin and Skin Structure Infections
This study is currently recruiting participants.
Verified by Cubist Pharmaceuticals, April 2009
First Received: July 7, 2008   Last Updated: April 7, 2009   History of Changes
Sponsored by: Cubist Pharmaceuticals
Information provided by: 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 7-17 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 IV

MedlinePlus related topics: Skin Conditions
Drug Information available for: Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Clindamycin palmitate Daptomycin Vancomycin Penicillins
U.S. FDA Resources
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

Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • Safety of daptomycin [ Time Frame: First dose through end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of daptomycin [ Time Frame: End of Therapy and Test-of-Cure Visits ] [ Designated as safety issue: No ]
  • Pharmacokinetics of daptomycin [ Time Frame: Day 3 (5 timepoints) ] [ Designated as safety issue: No ]

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
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)
Comparator: Active 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711802

Contacts
Contact: Andrea Clarke 781-860-8660 ext 8458 andrea.clarke@cubist.com

Locations
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
Sponsors and Collaborators
Cubist Pharmaceuticals
Investigators
Study Director: Peter Pertel, MD Cubist Pharmaceuticals
  More Information

No publications provided

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

Keywords provided by Cubist Pharmaceuticals:
Complicated
Skin
Structure

Study placed in the following topic categories:
Daptomycin
Anti-Bacterial Agents
Clindamycin
Skin Diseases, Infectious
Clindamycin-2-phosphate
Skin Diseases
Vancomycin

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009