Clinical Trial: Safety and Efficacy Study of Daptomycin Compared to Active Comparator in Pediatric Participants With Acute Hematogenous Osteomyelitis (AHO) (MK-3009-006)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Randomized, Double-Blinded Comparative Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daptomycin Versus Active Comparator in Pediatric Subjects With Acute Hematogenous

Brief Summary: The purpose of the study is to determine whether daptomycin is effective and safe in the treatment of pediatric participants with AHO when compared to vancomycin (or equivalent) or nafcillin (or β-lactam equivalent).

Detailed Summary:

Acute hematogenous osteomyelitis is a common problem in the pediatric population, affecting approximately 5/10,000 children each year and accounting for approximately 1% of all pediatric hospitalizations. In children, osteomyelitis arises from bacteremic seeding of the bone metaphysis.

Daptomycin, is a cyclic lipopeptide antibacterial active against most clinically significant gram-positive pathogens including drug-resistant strains such as Methicillin Resistant Staphylococcus (S.) aureus (MRSA) and Methicillin Susceptible S. aureus (MSSA). Daptomycin has proven clinical efficacy in adults in the treatment of complicated skin and skin structure infections (cSSSI) caused by aerobic gram-positive pathogens and the treatment of S. aureus bloodstream infections (bacteremia; SAB), including those complicated by right-sided infective endocarditis, caused by MSSA and MRSA. Although not indicated for osteomyelitis, daptomycin has been successfully used to treat osteoarticular infections in adults and children as salvage therapy and at medical centers with increasingly high rates of vancomycin resistant organisms.

In addition, more comparative clinical trials are needed in pediatric AHO to better elucidate the optimal treatment regimen and clinical response.


Sponsor: Cubist Pharmaceuticals LLC

Current Primary Outcome: Percentage of participants with clinical improvement in the 3 general categories of Pain, Inflammation, and Limb Function based on the Investigator's overall assessment of severity of each of the symptom categories. [ Time Frame: Study Day 5 ]

The Investigator will assess the general categories and clinical symptom parameters of AHO


Original Primary Outcome: Efficacy of daptomycin measured by clinical improvement in the 3 general categories of Pain, Inflammation, and Limb Function based on the Investigator's overall assessment of severity of each of the symptom categories. [ Time Frame: Study Day 5 ]

The Investigator will assess the general categories and clinical symptom parameters of AHO once at baseline; twice daily while subject is hospitalized and receiving IV study drug.


Current Secondary Outcome:

  • Percentage of participants with clinical improvement measured as a composite end point of pain, inflammation, limb function, body temperature, and C-reactive protein [ Time Frame: Up to study Day 5 ]
  • Percentage of participants with a favorable clinical outcome [ Time Frame: Baseline (within 48 hours prior to first dose of IV study drug) - and up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77) ]
  • Percentage of participants with a clinical cure or a favorable microbiological response by baseline pathogen at Test of Cure [ Time Frame: Baseline (within 48 hours prior to first dose of IV study drug) - and Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77) ]
  • Percentage of participants with sustained clinical improvement [ Time Frame: Baseline (within 48 hours prior to first dose of IV study drug) - up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77) ]
  • Percentage of participants with a a favorable microbiological response at Test of Cure [ Time Frame: Baseline (within 48 hours prior to first dose of IV study drug) - and Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77) ]


Original Secondary Outcome: Efficacy of daptomycin versus comparator in pediatric subjects with AHO [ Time Frame: Baseline (within 48 hours prior to first dose of IV study drug) - Test of Cure (21-35 days after last dose of IV study drug) ]

  1. Clinical improvement as composite end point of pain, inflammation, limb function, body temperature, and C-reactive protein measured at End of IV, End of Therapy, and Test of Cure.
  2. Microbiological outcome at Test of Cure
  3. Microbiological outcome by baseline pathogen at Test of Cure
  4. Sustained clinical improvement at End of Therapy and Test of Cure


Information By: Cubist Pharmaceuticals LLC

Dates:
Date Received: August 9, 2013
Date Started: September 2013
Date Completion:
Last Updated: February 22, 2017
Last Verified: February 2017