Comparing short versus long courses of intravenous antibiotics for diabetic foot infectio

Not Applicable

Withdrawn

• Conditions: Diabetic foot infection; Osteomyelitis; Infection - Other infectious diseases; Metabolic and Endocrine - Diabetes; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12619000407190
• Lead Sponsor: Royal Perth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-13
• Last Update Posted: 22 October 2019

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis of definite osteomyelitis at the amputation site as per 2008 IWGDF consensus definition (modified to include radionuclide imaging and to exclude localised clinical signs of infection treated as a superficial wound infection with an antibiotic for < 1 week) by the blinded endpoint review committee. The committee will determine by consensus the osteomyelitis diagnostic category (definite, probable, possible or unlikely) by reviewing study data redacted for any information that may betray treatment allocation.[Six months from start of treatment];Complete healing of the amputation site at 6 months as defined by full epithelialisation, after debridement of callus, lasting for at least 2 weeks. Primary outcome arbitration at the interim analysis and at the final analysis will be performed using the database, wound dimension and clinical images by two independent senior clinicians blinded (not investigators) to the intervention.[Six months from start of treatment]