A direct comparison of two intravenous antibiotics for the treatment of diabetic foot infections in adults

Phase 4

• Conditions: Diabetic foot infection; Metabolic and Endocrine - Diabetes; Infection - Other infectious diseases

• Registration Number: ACTRN12620000230954
• Lead Sponsor: Gold Coast Hospital and Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-25
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 484

Inclusion Criteria

18 years of age and older

Diabetes mellitus (type 1 or 2)

Moderate (Grade 3) diabetic foot infection (IDSA grading)

Exclusion Criteria

Severe (Grade 4) infection
Pregnant women
Documented allergy to penicillin
Received greater than 24hrs of trial drug prior to enrolment
Eligible for targeted therapy (i.e. have deep specimen bacteriological culture results).
Severe renal impairment (eGFR <10mL/min) or requiring renal replacement therapy
Unable to give consent for trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants achieving treatment success<br><br>Definition of treatment success: <br><br>For those who have a PEDIS score greater than 7 or vascular surgical opinion of requiring operative intervention at baseline: <br><br>No worsening of IDSA category – i.e. remains at category 3 (Moderate) or improves to category 2 (mild) or category 1 (uninfected); <br><br>For those who have a PEDIS score < 7 or vascular surgical opinion of NOT requiring operative intervention at baseline: <br><br>Improvement in IDSA category – i.e. improves to category 1 (uninfected) [Day 3, 5, 7, 10, 14, discharge, 1 month, 2 months, 3 months]