Comparison of intravenous Amoxicillin/Clavulanate to Piperacillin/Tazobactam for the empiric treatment of moderate diabetic foot infections in adults (CAPTAIN): Study protocol for a pragmatic, non-inferiority, randomised trial. 

  • Forman, Lee (Project Lead)
  • Alcorn, Kylie (Chief Investigator)
  • Jackson, Mark (Partner Investigator)
  • Cross, Jack (Partner Investigator)
  • Henry, David (Associate Investigator)
  • Jones, Mark (Associate Investigator)
  • Douglas, Sharon (Project Manager)
  • Bhamidi, Venu (Associate Investigator)
  • Butcher, William (Associate Investigator)
  • Stehlik, Paulina (Partner Investigator)

Project: Research

Project Details

Description

2019 Gold Coast Health Collaborative Research Grant
Scheme $100,000 AUD

Plain Language description

BACKGROUND
Diabetic foot infections (DFI) are a common complication in diabetic patients and require multi-disciplinary input for optimal management. Broad spectrum antimicrobial therapy is indicated for empiric treatment of moderate DFI. Pseudomonas aeruginosa is a frequent coloniser and specific anti-pseudomonal treatment, such as Piperacillin\Tazobactam, is required if this pathogen is to be targeted. Current Australian guidelines recommend Amoxicillin\Clavulanate for empiric treatment of moderate DFI, but there is a lack of good quality randomized trials comparing these agents. This study will evaluate whether intravenous Amoxicillin\Clavulanate is non-inferior to intravenous Piperacillin\Tazobactam for the empiric treatment of moderate DFI in hospitalised adult patients.

METHODS
This will be a 1:1 allocation, two-armed, triple blind, parallel, non-inferiority pragmatic randomised trial. Patients will be eligible if they have been admitted to hospital for a moderate diabetic foot infection requiring empiric IV antibiotics and have a history of diabetes mellitus (type 1 or 2). In addition to usual care, patients will be randomized to receive either empiric intravenous Amoxicillin\Clavulanate or Piperacillin\Tazobactam and will be followed up for a period of three months after randomisation. The primary outcome will be treatment success, defined as improvement or no worsening of International Working Group on the Diabetic Foot classification. Secondary endpoints include time to treatment success, length of hospital stay, number of unplanned operations\re-admissions and all-cause mortality.

DISCUSSION
If non-inferiority of Amoxicillin\Clavulanate is demonstrated its preference, due to narrower spectrum and associated reduction of selection pressure, will confirm current clinical practice and support the existing Australian treatment guidelines for DFI requiring intravenous antibiotics.TRIAL REGISTRATIONWHO Universal Trial Number: U1111-1247-8384; Australian New Zealand Clinical Trial Registry: ACTRN12620000230954pURL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379219&isReview=true Registered on 25/02/2020
AcronymCAPTAIN trial
StatusActive
Effective start/end date7/10/20 → …