None listed
Conditions
Brief summary
In patients with diabetes, foot ulceration and infection occur commonly, and are associated with significant morbidity and use of health service resources. Diabetic foot infections are usually associated with ulcers, and can spread from the soft tissue to involve underlying bone (osteomyelitis). Diabetic foot infection with osteomyelitis (DFO) is associated with delayed ulcer healing and increased risk of amputation. Current guidelines for treatment of osteomyelitis include a prolonged course (4–6 weeks) of intravenous antibiotics, However, this requires hospital admission and/or use of ambulatory care nursing services, as well as establishment of intravenous access for the duration of therapy, all of which place considerable burden on health services and the individual patient. Also, the antibiotic-related costs are much higher than oral therapy. Despite this, there is no evidence to suggest that oral therapy results in inferior outcomes. We hypothesise that, the use of oral antibiotics, particularly agents with high bioavailability, good tissue penetration and activity against the known or likely pathogens, might be effective and potentially less costly than intravenous therapy for DFO.
Interventions
Early Transition to Orals: Participants randomised to the experimental arm will receive at least one but no more than seven days (from start of current treatment course) of intravenous antibiotics before transitioning to an oral antibiotic regime. The antibiotic agent(s), dose(s) and duration will be individually selected by an Infectious Disease specialist for each participant.
Intervention adherence will be assessed by use of the Brief Medication Questionnaire at week 3-4 after start of treatm
Early Transition to Orals: Participants randomised to the experimental arm will receive at least one but no more than seven days (from start of current treatment course) of intravenous antibiotics before transitioning to an oral antibiotic regime. The antibiotic agent(s), dose(s) and duration will be individually selected by an Infectious Disease specialist for each participant. Intervention adherence will be assessed by use of the Brief Medication Questionnaire at week 3-4 after start of treatment with a target of >80% of prescribed doses.
Sponsors
Royal Perth Hospital
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 inpatients requiring surgical management for diabetic foot infection Positive bone chip (culture or microscopy) post-surgical procedure or negative bone chip (culture or microscopy)with high clinical suspicion for a residual osteomyelitis Type 1 or 2 diabetes mellitus Infection below ankle Likely to be able to be followed at health facility for subsequent six months Has received 7 days or less of intravenous therapy since admission to the hospital Is willing and able to give informed consent
Exclusion criteria
Patients with toe pressure < 30mmHg despite revascularisation An infection for which (as per ID Physician’s opinion) there are no suitable antibiotic choices to permit randomisation between the two arms of the trial (for example, where organisms are only sensitive to intravenous antibiotics) Systemic sepsis (eg. hypotension requiring inotropic support, blood cultures positive for Staphylococcus aureus) or other indications that mandate prolonged intravenous antibiotics Significant restricted therapeutic options (to either intravenous or oral antibiotics alone) because of patient or microbiological factors (eg. allergy, drug resistance) Pregnant women
Outcome results
None listed