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

PHASE3CompletedINTERVENTIONAL
Enrollment

149

Participants

Timeline

Start Date

September 13, 2013

Primary Completion Date

June 14, 2016

Study Completion Date

December 20, 2016

Conditions
Acute Hematogenous Osteomyelitis
Interventions
DRUG

Daptomycin

IV daptomycin Infusion A in 12 to \<18 years old (7 mg/kg); in 7 to \< 12 year olds (9 mg/kg); in 24 months to \<7 year olds (12 mg/kg); in 12 to \<24 month olds (12 mg/kg). Infused over 60 minutes ± 10 minutes once daily followed by up to 3 dummy infusions every 6 hours (q6h) infused over 60 (± 10) min to maintain the blind.

DRUG

Vancomycin (or equivalent)

IV vancomycin (or equivalent) (Infusions A,B,C,D), 10 to 15 mg/kg, infused over 60 (± 10) minutes q6h (± 1 hour)

DRUG

Nafcillin (or equivalent)

IV nafcillin (or β-lactam equivalent) (Infusions A,B,C,D) at 100-200 mg/kg/day, in divided doses infused over 60 (± 10) min q6h (± 1 hour)

All Listed Sponsors
lead

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

NCT01922011 - Safety and Efficacy Study of Daptomycin Compared to Active Comparator in Pediatric Participants With Acute Hematogenous Osteomyelitis (AHO) (MK-3009-006) | Biotech Hunter | Biotech Hunter