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

Comparison of intravenous Amoxicillin/Clavulanate to Piperacillin/Tazobactam for the empiric treatment of moderate diabetic foot infections in adults: A pragmatic, non-inferiority, randomised trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000230954

Acronym

CAPTAIN

Enrollment

484

Registered

2020-02-25

Start date

2020-03-16

Completion date

2021-11-30

Last updated

2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Purpose: The most recent national antibiotic recommendations for moderate DFI is to treat with IV Amoxicillin/Clavulanate (AUG). Previous guidelines recommended Piperacillin/tazobactam (PTZ) but was changed to the current recommendation based on largely expert opinion and anecdotal evidence. Study hypothesis: AUG is non-inferior to PTZ in adults in empiric treatment of moderate DFI and can therefore be safely used as first line empiric therapy Intervention: Participants will be randomised to receive either intravenous PTZ or intravenous AUG for at least 48hrs and ending at the direction of the treating clinician.

Interventions

Amoxicillin/Clavulanic Acid 2.2g three times daily intravenously or Amoxicillin/Clavulanic Acid 1.2g twice daily intravenously (if eGFR <20mL/min) Duration: at least 48hrs and ending at the direction of the treating clinician.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results