Comparative Evaluation of the Safety & Efficacy of Daptomycin Versus SOC in 2 - 17 yr Olds With Staphylococcus Aureus Bacteremia

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Cubist Pharmaceuticals Holdings LLC
Information provided by (Responsible Party):
Cubist Pharmaceuticals Holdings LLC Identifier:
First received: November 5, 2012
Last updated: June 24, 2015
Last verified: June 2015

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
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 Holdings LLC:

Primary Outcome Measures:
  • Assess the safety of i.v. daptomycin versus standard of care antibiotics in pediatric subjects aged 2 - 17 years of age with bacteremia. [ Time Frame: Administration of first dose through the last follow-up visit; an expected time of 5-77 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare the efficacy of i.v. daptomycin versus standard of care antibiotics in pediatric subjects aged 2 - 17 years of age with bacteremia caused by S. aureus. [ 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 ]
  • Determine exposure by measuring plasma levels of daptomycin at pre-dose (trough) and end of infusion (Cmax) to explore exposure-response analyses in pediatric subjects aged 2 - 17 years of age with bacteremia. [ Time Frame: Between days 3 and 5 of treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: December 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (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.


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

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
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 identifier: NCT01728376

Contact: Laura Sadowski 781-860-8497

  Show 70 Study Locations
Sponsors and Collaborators
Cubist Pharmaceuticals Holdings LLC
Study Director: Erik Deurell, MD Cubist Pharmaceuticals Holdings LLC
  More Information

No publications provided

Responsible Party: Cubist Pharmaceuticals Holdings LLC Identifier: NCT01728376     History of Changes
Other Study ID Numbers: DAP-PEDBAC-11-02
Study First Received: November 5, 2012
Last Updated: June 24, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bacterial Infections
Pathologic Processes
Systemic Inflammatory Response Syndrome
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses processed this record on September 03, 2015