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

Recruiting Phase 3 Interventional Study
Complicated Intra-abdominal Infection
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
16 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,166 (estimated)
Sponsor
Sarah Cockayne · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Adults (≥ 16 years) with cIAI\* (see cIAI definition) * Being treated with antibiotics until the point of randomisation, but within 10 days of initiation of effective antibiotic treatment\*\* for cIAI * Ability to provide informed consent by the patient or their consultee. * M…
Contacts

Sarah Cockayne

01904 321736

ytu-extend-trial@york.ac.uk

CONTACT

Puvan Tharmanathan, PhD

01904 321844

puvan.nathan@york.ac.uk

CONTACT