Overview

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

Status:
Completed

Trial end date:
2016-12-20

Target enrollment:

Participant gender:

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). 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.

Phase:

Phase 3

Details

Lead Sponsor:

Cubist Pharmaceuticals LLC

Treatments:

Daptomycin
Nafcillin
Vancomycin