None listed
Conditions
Brief summary
This is a pilot feasibility and safety randomised controlled trial evaluating the optimal duration of antibiotic therapy (4 versus 6 weeks) for the treatment of pelvic osteomyelitis in people living with spinal cord injury, hypothesising that a shorter 4-week treatment course is feasible, safe, and non-inferior to the current 6-week standard with respect to clinical outcomes, while reducing antibiotic exposure and treatment-related harms.
Interventions
This is a pilot, feasibility and safety, randomised controlled trial to be conducted in patients admitted to the Victorian Spinal Cord Service at Austin Health in Melbourne, Australia.
Patients with spinal cord injury (SCI) and clinical, radiological, microbiological, or histopathological evidence of osteomyelitis (OM) for multi-disciplinary management will be identified by investigators and assessed for eligibility
Patients in the INTERVENTION group will receive 4 weeks of antibiotic therap
This is a pilot, feasibility and safety, randomised controlled trial to be conducted in patients admitted to the Victorian Spinal Cord Service at Austin Health in Melbourne, Australia. Patients with spinal cord injury (SCI) and clinical, radiological, microbiological, or histopathological evidence of osteomyelitis (OM) for multi-disciplinary management will be identified by investigators and assessed for eligibility Patients in the INTERVENTION group will receive 4 weeks of antibiotic therapy (either intravenous or oral) from date of commencement of effective antibiotic therapy, following surgical source control. Antibiotic therapy will be decided by a treating clinician independent of, and prior to, randomization. The antibiotic therapy will be determined by clinical microbiology and antimicrobial susceptibility data independently of subsequent consent and enrolment in the trial. Adherence to medication will be monitored using medical administration records during hospitalisation, community dispensing records when in outpatients, and patient reported adherence.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patient 18 years and older with spinal cord injury Decubitus pressure injury with clinical, radiological, microbiological or histopathological evidence of osteomyelitis. Planned for multidisciplinary management including surgical debridement, infectious diseases consultation and spinal rehabilitation consultation Willing and able to consent
Exclusion criteria
Treating clinician impression of superficial soft tissue infection only, without underlying osteomyelitis Not appropriate for definitive surgical management within the Spinal Unit (e.g. palliative trajectory, not for operative management). Concomitant S. aureus bacteraemia Concomitant septic arthritis without surgical source control Multifocal areas of osteomyelitis within the pelvis, not amenable to surgical debridement or complete source control
Outcome results
None listed