None listed
Conditions
Brief summary
This study aims to investigate the best treatment of bone infections for children in New Zealand. NZ has one of the highest incidence of osteomyelitis in developed countries. Current hospital management includes 3-6 weeks of intravenous antibiotics, partly administered by caregivers at home, via a long intravenous line inserted under general anaesthetics. This study investigates if oral antibiotics following a short duration of intravenous therpay are an effective and safe treatment.
Interventions
Intravenous Cephazolin 50mg/kg every 8 hours or Flucloxacillin 50mg/kg every 6 hours until clinical defervescence, then change to high dose oral Cephalexin 25mg/kg every 6 hours. Antibiotics are given for a minimum 3 week duration. Weekly follow up programme until children are cured clinically, which will be the endpoint of antibiotic treatment . Children are anticipated to have no more that 6 weeks of antibiotics unless clincially indicated, with the reason clearly stated. Children are excluded
Intravenous Cephazolin 50mg/kg every 8 hours or Flucloxacillin 50mg/kg every 6 hours until clinical defervescence, then change to high dose oral Cephalexin 25mg/kg every 6 hours. Antibiotics are given for a minimum 3 week duration. Weekly follow up programme until children are cured clinically, which will be the endpoint of antibiotic treatment . Children are anticipated to have no more that 6 weeks of antibiotics unless clincially indicated, with the reason clearly stated. Children are excluded from the study if they do not acheive clinical defervescence by 10 days.
Sponsors
Diana Lennon
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to 15 Years
Healthy volunteers
Yes
Inclusion criteria
Children who presented with a diagnosis of actute osteomyelitis with or without septic arthritis. Osteomyelitis is defined as an acute disease with symptoms, clinical or radiological signs compatible with the disease, and with or without positive microbiology from a local bony lesion or blood culture. Septic arthritis is defined by an acute disease with positive inflammatory or microbiology result in a joint aspirate.
Exclusion criteria
1) Chronic osteomyelitis 2) Vertebral osteomyelitis 3) Atypical causative organism including gram negative bacteria and resistant organisms 4) Children with a history of compound fracture or penetrating injury 5) Immunodeficiency 6) Multifocal disease 7) Failure to achieve defervescence within 10-14 days from initiation of intravenous antibiotics 8) Children unable to take oral antibiotics 9) History of penicillin anaphylaxis
Outcome results
None listed