A Comparative Evaluation of the Safety and Efficacy of Daptomycin Versus Standard of Care in Pediatric Subjects Two - Seventeen Years of Age With Bacteremia Caused by Staphylococcus Aureus

This study is currently recruiting participants.
Verified January 2014 by Cubist Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01728376
First received: November 5, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

The intent of this study is to describe the safety and efficacy of daptomycin versus standard of care (SOC) in pediatric subjects aged 2-17 years with bacteremia caused by S. aureus.


Condition Intervention Phase
Bacteremia
Drug: Daptomycin
Drug: Comparator (Vancomycin, Semi-synthetic penicillin, First-generation cephalosporins, Clindamycin)
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: A Comparative Evaluation of the Safety and Efficacy of Daptomycin Versus Standard of Care in Pediatric Subjects Two - Seventeen Years of Age With Bacteremia Caused by Staphylococcus Aureus.

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • Safety of daptomycin measured by the incidence of treatment-emergent adverse events, vital signs, echocardiogram (if performed) and clinical laboratory tests, use of concomitant medications,physical and neurological exam results. [ Time Frame: Administration of first dose through the last follow-up visit; an expected average of 9-11 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of daptomycin will be based on Investigator's assessment of clinical response (cure, improved, failure or non-evaluable) at the Test of Cure (TOC) visit. [ Time Frame: EOT(after completion of i.v. or oral therapy, up to 6 weeks) and TOC (7-14 days after the last dose of study medication) ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: December 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daptomycin Drug: Daptomycin
i.v daptomycin given at 7 mg/kg (ages 12-17 years); 9 mg/kg (ages 7-11 years); 12 mg/kg (ages 2-6 years)
Other Name: Cubicin
Active Comparator: standard of care; comparator
vancomycin, Semi-synthetic penicillin,First-generation cephalosporins, Clindamycin
Drug: Comparator (Vancomycin, Semi-synthetic penicillin, First-generation cephalosporins, Clindamycin)
Administered per standard of care
Other Name: Vancomycin, Semi-synthetic penicillin, First-generation cephalosporins, Clindamycin

Detailed Description:

Staphylococcus aureus causes a series of invasive diseases in adults and children, including bacteremia. Infections due to S. aureus in children, particularly those due to methicillin resistant S. aureus (MRSA), are a growing world-wide public health concern.

Daptomycin, a cyclic lipopeptide antibacterial agent, shows rapid in vitro bactericidal activity with concentration-dependent killing for Gram-positive organisms, including S. aureus. Surveillance studies have demonstrated a daptomycin MIC90 of 0.5µg/ml for both methicillin-susceptible Staphylococcus aureus (MSSA) and MRSA with >99% of MRSA isolates being categorized as susceptible by the Food and Drug Administration (FDA), European Committee of antimicrobial susceptibility testing (EUCAST) and Clinical and Laboratory Standards Institute (CLSI) breakpoints (5). Clinical trials in adults demonstrated that daptomycin was safe and efficacious in complicated skin and skin structure infections (cSSSI) and bloodstream infections caused by S. aureus, including right-sided infective endocarditis (RIE). However, information on the safety and efficacy of daptomycin for use in children is lacking.

The intent of this study in children is to confirm the safety of daptomycin at mean steady state systemic exposures (AUC) similar to those reported for adults treated at 6 mg/kg for bacteremia.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be included in this study, participants must:

  • Sign a parental consent form; if appropriate, sign an assent form
  • Be between 2 and 17 years of age
  • Have proven or probable bacteremia caused by Staphylococcus aureus based on the traditional culture result, rapid diagnostic test or Gram stain
  • If female of childbearing potential, must not be pregnant or nursing and take appropriate measures to not get pregnant during the study
  • If male, must take appropriate measures to not get partner pregnant
  • Able to comply with the protocol requirements

Exclusion Criteria:

Participants will not be allowed into the study if they:

  • Have received a certain amount of antibacterial therapy specific for current bacteremia unless it is demonstrated that the organism is resistant to the given antibacterial;
  • Anticipate to require other antibiotics that may be potentially effective against S. aureus;
  • Have shock or hypotension unresponsive to standard therapy;
  • Have received an investigational product or have participated in an experimental procedure within 30 days;
  • Have an intolerance or hypersensitivity to daptomycin;
  • Have renal insufficiency;
  • Have prior history or current evidence of muscle damage (rhabdomyolysis; significant creatine phosphokinase (CPK) elevation);
  • Have history of clinically significant muscular disease, nervous system or seizure disorder, including unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barré or spinal cord injury;
  • Have S. aureus pneumonia, empyema, meningitis, or endocarditis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728376

Contacts
Contact: Claudia Abbes 781-860-8201 claudia.abbes@cubist.com

  Show 61 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: NCT01728376     History of Changes
Other Study ID Numbers: DAP-PEDBAC-11-02
Study First Received: November 5, 2012
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Clindamycin
Clindamycin-2-phosphate
Vancomycin
Daptomycin
Cephalosporins
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 April 17, 2014