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EXTENDed Antibiotic Durations Compared to Standard Durations for Patients With Complicated Intra-abdominal Infection.

NCT05148702 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1166

Last updated 2024-12-24

No results posted yet for this study

Summary

A multicentre, open label, two-arm, parallel group, pragmatic, randomised controlled trial with internal pilot. A total of 1166 consenting adult patients with cIAI will be recruited and randomised on a 1:1 basis between 28-days antibiotics and standard care antibiotics. Patients will be followed up for 180 days to determine cost effectiveness and the rate of treatment failure in each group.

Conditions

  • Complicated Intra-abdominal Infection

Interventions

DRUG

Antibiotic - standard duration

Clinician decided antibiotic and duration of treatment

DRUG

Antibiotic - fixed-extended-duration

Clinician decided antibiotic for a fixed duration of 28 days.

Sponsors & Collaborators

  • University of York

    collaborator OTHER

  • University of Birmingham

    collaborator OTHER

  • Chesterfield Royal Hospital NHS Foundation Trust

    collaborator UNKNOWN

  • University of Leeds

    collaborator OTHER

  • The Leeds Teaching Hospitals NHS Trust

    collaborator OTHER

  • Sarah Cockayne

    lead OTHER

Principal Investigators

  • Andrew Kirby, MD · University of Leeds

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05148702 on ClinicalTrials.gov