Daptomycin in paediatric patients with AHO (infection of the bone)
Research type
Research Study
Full 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
IRAS ID
155403
Contact name
Faust Saul
Contact email
Sponsor organisation
Cubist Pharmaceuticals, Inc.
Eudract number
2013-000864-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 30 days
Research summary
This study is investigating the efficacy and safety of an experimental drug called daptomycin for the treatment of Acute Haematogenous Osteomyelitis (AHO), an uncommon invasive infection in the paediatric population. At present MRSA bone infection is rare in UK children, but this study is important to ensure safety and efficacy data on both fully sensitive and resistant staphylococcus causing invasive bone infections in children. There are no approved antibiotics for treatment of AHO caused by MRSA and this is the first prospective, randomized controlled study in pediatric AHO.
Daptomycin, is a once-daily administered antibacterial active against most clinically significant gram-positive pathogens including drug-resistant strains. At least 204 children aged from 1 to 17 will be enrolled across approximately 130 treatment centres worldwide. The study is randomised and the patients will be treated intravenously (IV) with either daptomycin or an active comparator. In the UK this comparator will be ceftriaxone, also administered once daily therefore no placebo (dummy) infusions are required in participating UK children. This study is double-blinded so no-one will know which treatment is being given. There is also an option to switch to a known oral treatment if certain criteria are met as is the UK standard of care. The study infusions will be given for at least 4 days and no longer than 42 days. In total participation will be 6 months.
Due to the variety of drugs used in standard of care worldwide, the comparator drugs vary according to local practice.
In the UK, only children = 6 years will be enrolled as daptomycin is known to have little activity against the bacteria Kingella kingae which pilot studies in the UK and France have shown to be the cause of up to half of bone infections in children = 5 years. In older children and adults, Staphylococcus aureus is the main bacteria causing bone (and joint) infections.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
14/SC/1311
Date of REC Opinion
27 Oct 2014
REC opinion
Favourable Opinion