EXTENDed Antibiotic Durations Compared to Standard Durations for Patients With Complicated Intra-abdominal Infection.
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16+
SponsorSarah Cockayne
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.
Eligibility criteria
Qualifiers
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.
More than 72 hours*** of active in-patient management for the patients cIAI is required
Disqualifiers
Perforated gastric ulcer or duodenal ulcer treated within 24 hours of the onset of symptoms.
Traumatic injury to the bowel (including iatrogenic or intra-operative) treated within 12 hours of injury.
Uncomplicated diverticulitis defined as an episode with a short history and with clinical signs of diverticulitis, with an increased body temperature and inflammatory parameters, verified by computed tomography (CT), and without any sign of complications such as abscess, free air or fistula.
Grade 1 to 3 appendicitis. To be eligible patient must have Grade 4 or 5 appendicitis defined by the 2017 American Association for the Surgery Trauma Grading System with either generalised peritonitis at surgery, or no or partial source control e.g. radiological drainage
Trial design
Treatments tested in this trial
- Antibiotic - standard duration
- Antibiotic - fixed-extended-duration
Treatment groups
1,166 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sarah Cockayne
Lead sponsor
University of York
Sponsor institution
University of York
Collaborator
University of Birmingham
Collaborator
Chesterfield Royal Hospital NHS Foundation Trust
Collaborator
University of Leeds
Collaborator
The Leeds Teaching Hospitals NHS Trust
Collaborator
Source ClinicalTrials.gov