Acute Hematogenous Osteomyelitis Clinical Trial
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 Osteomyelitis Due to Gram-Positive Organisms
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). The primary hypothesis is that daptomycin is non-inferior compared with vancomycin (or equivalent) or nafcillin (or β-lactam equivalent) with respect to improvement in Pain, Inflammation, and Limb Function on or before study Day 5.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03846804 -
Next-Generation Sequencing for Pathogen Detection and Quantification in Children With Musculoskeletal Infections
|
N/A |