None listed
Conditions
Interventions
Vial: Powder lyophylisate for solution for infusion for Intravenous.
Daptomycin Treatment Group - IV Drugs and Doses:
• Cohort 1, Infusion A: daptomycin 7 mg/kg infused over 60 (± 10) minutes on
-lactam) for subjects where MRSA is not suspected
Sponsors
Cubist Pharmaceuticals LLC.,
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: Subjects are required to meet ALL of the following inclusion criteria: 1. Informed consent in writing from parent(s) or legally-acceptable representative(s) and, informed assent from subject (if age appropriate according to local requirements) 2. Male or female, 1 year to < 18 years old (subject must be randomized before 18th birthday) 3. Presence of AHO warranting hospitalization and IV antibacterial therapy Additional information is described in the Protocol
Exclusion criteria
Exclusion criteria: Subjects must NOT meet any of the following exclusion criteria: 1. Documented history of any hypersensitivity or allergic reaction to daptomycin, vancomycin, or any β-lactam antibacterial agent 2. Diagnosis of contiguous septic arthritis associated with AHO at baseline 3. AHO of the spine or pelvis or AHO involving multiple locations (2 or more bones) 4. Chronic osteomyelitis or symptoms of osteomyelitis exceeding 14 days Additional information is described in the protocol
Countries
Afghanistan, Argentina, Australia, Brazil, Chile, Colombia, France, Germany, Greece, Guatemala, Hungary, Israel, Italy, Korea South, Romania, Spain, Turkey, Ukraine, United States
Contacts
Public ContactElizabeth Rospigliosi
INVENTIV HEALTH CLINICAL PERU S.A
Outcome results
None listed