Duration of intravenous antibiotic therapy for children with acute osteomyelitis or septic arthritis: a feasibility study.

Background: There is little current consensus regarding the route or duration of antibiotic treatment for acute osteomyelitis (OM) and septic arthritis (SA) in children. Objective: To assess the overall feasibility and inform the design of a future randomised controlled trial (RCT) to reduce the duration of intravenous antibiotic use in paediatric OM and SA. Design: a): Prospective service evaluation (cohort study) to determine the current disease spectrum and UK clinical practice in paediatric OM/SA; b) prospective cohort sub-study to assess the use of targeted PCR in diagnosing paediatric OM/SA: study; c) a qualitative study explored families views and experiences of OM/SA; and d)development of a core outcome set via systematic review of literature, Delphi clinician survey and stakeholder consensus meeting. Setting: 44 UK secondary and tertiary UK centres (service evaluation). Participants: Children with OM/SA Results: Data was obtained on 313 cases of OM/SA of which 218 (61.2%) were defined as simple disease and 95 (26.7%) complex. The epidemiology of paediatric OM/SA in this study was consistent with existing European data. Children who met oral switch criteria less than 7 days from starting intravenous antibiotics had less treatment failure (9.6%) than children who meet oral switch criteria after 7 days of intravenous therapy (16.1% where switch was between 1-2 weeks, 18.2% switch >2 weeks). In 24 of 32 simple cases (75%) and 8 of 12 complex cases (67%) in whom the targeted PCR was used a pathogen was detected. The qualitative study demonstrated the importance to parents and children of consideration of short and long term outcomes meaningful to families themselves. The consensus meeting agreed on the following outcomes: re-hospitalisation or recurrence of symptoms while on oral antibiotics, recurrence of infection, disability at follow-up,symptom free at 1 year, limb shortening or deformity, chronic osteomyelitis or arthritis,amputation or fasciotomy, death, need for paediatric intensive care and line infection. Oral switch criteria were identified, including resolution of fever for 48 hours or more, tolerating oral food and medicines, and pain improvement. Page 6 of 422 Limitations: Data were collected in a 6 month period which might not have been representative and follow up data for long term complications are limited. Conclusions: A future RCT would need to recruit from all tertiary and most secondary UK hospitals. Clinicians have implemented early oral switch for selected patients with simple disease without formal clinical trial evidence of safety. However, the current criteria by which decisions to make the oral switch are made are not clearly established or evidence based. Future work: An RCT in simple OM and SA comparing shorter or longer course IV therapy is feasible in children randomised after oral switch criteria are met after 7 days of intravenous therapy, excluding children meeting oral switch criteria in the first week of intravenous therapy. This study design meets clinician preferences and addresses parental concerns not to randomise prior to oral switch criteria being met.