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HIPAA Compliant
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Actively Recruiting

Phase 3
Age: 16Years +
All Genders
ID05148702

The EXTEND Trial Fixed-extended-duration Antibiotics 28 Days Compared to Standard Care Antibiotic Durations in Adult Patients With Complicated Intra-abdominal Infection and Their Impact on Treatment Failure

Led by Sarah Cockayne · Updated on 2024-12-24

1166

Participants Needed

36

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Sarah Cockayne

Lead Sponsor

U

University of York

Collaborating Sponsor

AI-Summary

What this Trial Is About

The trial investigates complicated intra-abdominal infections cIAIs, focusing on whether a fixed extended duration of 28 days of antibiotics is better than the standard care duration, which typically lasts 7 to 18 days. This is a multicenter, randomized controlled trial that aims to assess cost effectiveness and the rate of treatment failure over 180 days. The study responds to concerns that current treatments result in high relapse and extra-abdominal infection rates, while also addressing the balance between antibiotic resistance and treatment adequacy. Participants are randomly assigned to one of two groups one receiving antibiotics for a fixed duration of 28 days, and the other receiving standard care where the antibiotic duration is decided by their clinician. The trial will recruit 1166 adult patients from ICUs and hospital wards across about 30 NHS trust hospitals. Both groups receive antibiotics as prescribed, with the difference being the length of treatment determined by randomization. During the study, participants will complete quality of life questionnaires at the start and at 30, 60, and 180 days after randomization. They will also provide information on antibiotic use and healthcare resources. Researchers will review hospital records to track admissions, relapses, additional infections, and various health outcomes such as treatment failure within 180 days. The study is sponsored by the University of Leeds and includes comprehensive follow-up to evaluate clinical results and economic impact.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 16 years or older with complicated intra-abdominal infection (cIAI)
  • Currently being treated with antibiotics and within 10 days of starting effective antibiotic treatment for cIAI
  • Able to provide informed consent or have a consultee to provide consent
  • Require more than 72 hours of active in-patient management for cIAI
  • Likely to be admitted to a participating hospital if re-admitted during the trial
  • Included regardless of whether surgical or radiological source control procedures are performed
Not Eligible

You will not qualify if you...

  • Perforated gastric or duodenal ulcer treated within 24 hours of symptom onset
  • Traumatic bowel injury treated within 12 hours of injury
  • Uncomplicated diverticulitis without complications
  • Grade 1 to 3 appendicitis; only Grade 4 or 5 appendicitis eligible
  • Non-perforated cholecystitis
  • Ischemic or necrotic intestine without perforation
  • Uterine perforation treated within 6 hours of injury
  • Low-risk cIAI cases requiring more than 72 hours antibiotics not intended for inclusion
  • Current enrollment in another trial affecting antibiotic duration
  • Previous Clostridium difficile infection
  • Infected necrotic pancreatitis
  • Concomitant infections requiring 4 or more weeks of antibiotics
  • Peritoneal dialysis
  • Previously recruited for this trial
  • Treatment with Interleukin-6 inhibitors
  • High likelihood of death within 72 hours of randomization
  • Pre-decided treatment limitations linked to expected death
  • Persistent cIAI lasting more than 6 months
  • If appendix source exceeds 20% of participants, further appendix cases excluded

Research Team

S

Sarah Cockayne

P

Puvan Tharmanathan, PhD

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