Safety and Efficacy Study of Daptomycin in Pediatric Subjects (3 Months -17 Years)With Skin and Skin Structure Infections

This study has suspended participant recruitment.
(Enrollment is on hold until a full evaluation of the data for an ongoing animal toxicity study is completed and reviewed by Cubist and the external DMC.)
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00711802
First received: July 7, 2008
Last updated: November 27, 2013
Last verified: November 2013
  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 3 months -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 Three Months to Seventeen Years With Complicated Skin and Skin Structure Infections Caused by Gram-Positive Pathogens

Resource links provided by NLM:


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 1 or Day 3 (5 timepoints) ] [ Designated as safety issue: No ]
    PK sampling completed on Day 3 for cohorts 1 and 2. PK sampling completed on Day 1 for cohort 3. Sparse PK sampling (2 samples per patient) on days 1, 2 or 3 for cohort 4 and 5.


Estimated Enrollment: 420
Study Start Date: July 2008
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (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); at 10 mg/kg (ages 1-2); or 9 mg/kg (ages 3 months - <1 year)
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

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 3 months -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:   3 Months 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 3 months 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;
  • Known renal insufficiency (i.e. estimated creatinine clearance rate (CLcr)<80 mL/min/1.73m2, or suspected;
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 31 Study Locations
Sponsors and Collaborators
Cubist Pharmaceuticals
Investigators
Study Director: Hernando Patino, MD Cubist Pharmaceuticals
  More Information

No publications provided

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: November 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:
Complicated
Skin
Structure

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 20, 2014