A 28-day course of antibiotics could replace the current variable-length treatments for patients with severe abdominal infections, based on a new UK trial enrolling 1,166 patients. Complicated intra-abdominal infections are the second most common cause of sepsis in intensive care units, affecting between 33,000 and 215,000 people in the UK each year. Current practice leaves antibiotic duration to clinical judgement, but shorter courses may allow infections to relapse, requiring further surgery and more antibiotics. Early trial data suggest that longer, fixed-duration treatment delays relapse and reduces the need for radiological drainage, but no large UK randomised trial has tested this approach. If the EXTEND trial shows that 28 days of antibiotics is superior to standard care, the NHS could adopt a clear, evidence-based protocol for these infections. Patients would face fewer treatment failures, fewer readmissions, and fewer complications such as *C. difficile* or antimicrobial-resistant infections over the six months after diagnosis. The trial also includes a cost-effectiveness analysis, so funders will know whether the longer regimen saves money by reducing repeat procedures and hospital stays.
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Research question: Does the use of fixed-extended-duration antibiotics improve patient outcomes compared to standard antibiotic durations in patients with complicated intra-abdominal infection. Background: Complicated intra-abdominal infections (cIAIs) are the second most common source of sepsis on Intensive Care Units, and a major challenge on surgical wards with between 33,000-215,000 cases per year. Complications including death, cIAI relapse after antibiotic therapy and extra-abdominal infections are common in this at risk patient group. Complications require more antibiotic treatment and additional surgical interventions. Trial data shows longer antibiotic durations delay time to relapse, reduce the need for radiological drainage and may reduce extra-abdominal infections. Randomised controlled trial (RCT) data from the UK is needed to evaluate fixed-extended-durations of antibiotics for patients with cIAI before implementation in the NHS. Aim: To investigate the clinical and cost effectiveness of a fixed-extended-duration of 28-days antibiotic treatment compared to standard care for patients with cIAIs. Objectives: To complete a randomised parallel group comparison to determine if a fixed-extended-duration of 28-days antibiotic treatment is superior to standard care based on treatment failure assessed over 180 days from diagnosis. To conduct an economic evaluation to assess the cost-effectiveness of these comparisons and further modelling for long term effects. Methods: A multicentre, open label, 2-arm, parallel group, pragmatic, randomised controlled superiority trial with internal pilot and cost-effectiveness study. Eligible patients are adults with cIAI requiring >72 hours in-patient surgical care with or without a source control procedure. Intervention treatment will be a fixed-extended-duration of 28-days antibiotics for the treatment of cIAI and the comparator will be standard care antibiotic duration. The primary outcome will be treatment failure within 180 days of diagnosis. Secondary outcomes include Desirability of Outcome Ranking analysis, EQ-5D-5L, mortality, number/type of source control procedures, relapse of cIAI, length of hospital stay, re-admission, C. difficile infection, anti-microbial resistant infections and days of antibiotics within 180 days of diagnosis. The sample size will be 1166 based on an effect size of 10% assuming an event rate of 50% or more in the standard treatment arm. Participants will be randomised 1:1 between 28-days antibiotics and a standard care antibiotic duration stratified by post-operative cIAI vs non post-operative cIAI, surgical source control procedure vs no surgical source control procedure and ICU stay vs no ICU stay. Timelines for delivery: Six months is required for protocol development, ethical/HRA approval and trial/site set-up. Recruitment will take 36 months including a 12 month pilot, with a six month follow up period followed by a six month analysis phase. Anticipated impact and dissemination: This will be the first RCT to provide evidence for the use of fixed-extended-duration antibiotic durations in the treatment of cIAI, providing evidence required for adoption into clinical practice. Patients will potentially benefit from less treatment failure after cIAI treatment and long term improvements in quality of life. The trial will be disseminated via conference presentations, publications and to the public/patients supported by the EXTEND PPI group.
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