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Could a standard 28-Day antibiotic course beat flexible dosing for abdominal infections?

NCT ID NCT05148702

Disease control Sponsor: Lydia Flett Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This trial compares a fixed 28-day antibiotic course against standard care (where the duration is decided by the doctor) in adults hospitalized with complicated intra-abdominal infections. About 1,100 participants will be randomly assigned to one of the two approaches and followed for 180 days. The goal is to see whether the longer fixed course reduces treatment failure and is cost-effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
antibiotics (clinician-chosen) given for a fixed 28-day course
What this could lead to
If it works, a simple rule of giving 28 days of antibiotics could reduce treatment failure and improve recovery for people with serious abdominal infections.
What could go wrong
This is a large trial, but longer antibiotic use may increase side effects, drug resistance, or costs without clear benefit over current flexible durations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,166 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * More than 72 hours\*\*\* of active in-patient management for the patients cIAI is required * In the event that the patient is re-admitted to hospital during the trial period, they are likely to be admitted to a hospital participating in the EXTEND trial. Patients will be included in the trial whether or not they undergo surgical or radiological source control procedures. \* cIAI is defined by the following case definition: * A clinical presentation consistent with cIAI, plus * Fever (temperature of ≥ 37.8°C) and/or a neutrophilia (\> 7.5×109/L) and/or neutropaenia (\<1.8 x 109 /L) and/or intestinal pathogens cultured from sterile sites (closed peritoneum or blood) around the time of cIAI diagnosis, plus * Evidence of pathologic findings on radiologic examination, or * Evidence of pathologic findings at operation \*\* The first day of effective antibiotic treatment will be determined by the patient's clinical team or clinical research team. Antibiotics that do not count towards these 10 days of effective treatment are: * Antibiotic prophylaxis e.g., penicillin for splenectomy, elective surgery antibiotic prophylaxis, UTI prophylaxis * Treatment for other infections that is not effective for cIAI e.g., cystitis. Antibiotics that re often used for cystitis and aren't effective for cIAI include Cephalexin, Fosfomycin Trimethoprim, Nitrofurantoin, and Pivmecillinam. * Oral antibiotics prescribed to treat infection prior to hospitalisation * Previous courses of treatment antibiotics: A previous course is one stopped for 48 hours or more * The further 72 hours starts from the first day of effective antibiotic treatment i.e., for a patient admitted to hospital with a cIAI, 3 days of admission are needed. Where a patient is already in hospital e.g., a post operative patient, a further 3 days of admission are required starting from the point of the first day of effective antibiotic treatment. Exclusion Criteria: * 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 * Non-perforated cholecystitis. * Ischemic or necrotic intestine without perforation * Uterine perforation following uterine surgery treated \<six hours following injury. * cIAIs with a low risk of complications who may receive more than 72 hours antibiotics are not intended to be included, such as those listed above. Traumatic injury to the bowel (including iatrogenic or intra-operative) treated within 12 hours of injury, Uterine perforation following uterine surgery treated within six hours of injury, Perforated gastric ulcer or duodenal ulcer treated within 24 hours of the onset of symptoms). Clinician assessment on the eligibility of patients receiving more than 72 hours of in-patient surgical care and antibiotics for their cIAI may be required in patients who have clinically improved at this point and do not require active surgical care but remain in hospital and on antibiotics. * Current enrolment in another trial dictating antibiotic treatment duration. * Previous Clostridium difficile infection * Infected necrotic pancreatitis * Concomitant infection requiring ≥4 weeks antibiotic therapy including Intra-hepatic abscess/es planned to be treated with fixed-extended-duration antibiotics of 4 to 6 weeks antibiotics, osteomyelitis, and endocarditis. * Peritoneal dialysis * Previously recruited for the EXTEND trial * Treatment with Interleukin-6 Inhibitors * High likelihood of death within 72 hours of cIAI randomisation in the opinion of the local Investigator * Limitations in treatment decided before inclusion. Limitations in treatment that exclude patients from the EXTEND trial are those clinical decisions linked to an expectation the patient will die during this episode of infection. * Patient with persistent cIAI of more than 6 months duration A maximum of 20% of participants entering the trial can have a source of cIAI as the appendix. If 230 patients with appendix as the source are recruited, this will become an exclusion criteria for subsequent patients. Note: There are absolute exclusions that preclude trial participation. These include: C. difficile infection, Infected necrotic pancreatitis, Concomitant infection requiring ≥4 weeks antibiotic therapy, Treatment with Interleukin-6 Inhibitors, High likelihood of death within 72 hours of randomisation, Limitations in treatment decided before inclusion, Peritoneal dialysis, Previously recruited for the EXTEND trial, Patient with persistent cIAI of more than 6 months duration and a patient with persistent cIAI of more than 6 months duration. If a patient has two intraabdominal infections, the presence of one of the following ineligible infections does not make a patient ineligible if the other cIAI is eligible: 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, Ineligible cases of appendicitis (see exclusion criteria above), Uncomplicated cholecystitis, Ischemic or necrotic intestine without perforation, Uterine perforation following uterine surgery treated within six hours of injury or cIAI with a low risk of complications.

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Conditions

The condition(s) this trial relates to.

Infections infectious peritonitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Complicated intra-abdominal infection

Contacts and locations

Locations

  • Aneurin Bevan University Health Board

    Newport, United Kingdom

  • Barking, Havering and Redbridge University Hospitals Nhs Trust

    Romford, United Kingdom

  • Bolton NHS Foundation Trust

    Bolton, United Kingdom

  • Buckinghamshire Healthcare NHS Trust

    Aylesbury, United Kingdom

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London, United Kingdom

  • Chesterfield Royal Hospital NHS Foundation Trust

    Chesterfield, United Kingdom

  • County Durham and Darlington NHS Foundation Trust

    Darlington, United Kingdom

  • Cwm Taf Morgannwg University Health Board,

    Abercynon, United Kingdom

  • East Cheshire NHS Trust

    Macclesfield, United Kingdom

  • East Suffolk and North Essex NHS Foundation Trust

    Ipswich, United Kingdom

  • East Sussex Hospitals NHS Trust

    Saint Leonards-on-Sea, United Kingdom

  • Guys and St Thomas' NHS Foundation Trust

    London, United Kingdom

  • Hull University Teaching Hospitals NHS Trust

    Hull, United Kingdom

  • Hywel Dda University Health Board

    Aberystwyth, United Kingdom

  • Imperial College Healthcare NHS Trust

    London, United Kingdom

  • King'S College Hospital Nhs Foundation Trust

    London, United Kingdom

  • Lancashire Teaching Hospitals NHS Foundation Trust

    Preston, United Kingdom

  • Leeds Teaching Hospitals NHS Trust

    Leeds, United Kingdom

  • Manchester University NHS Foundation Trust

    Manchester, United Kingdom

  • NHS Grampian

    Aberdeen, United Kingdom

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    Norwich, United Kingdom

  • North Bristol NHS Trust

    Bristol, United Kingdom

  • North Cumbria Integrated Care NHS Foundation Turst

    Carlisle, United Kingdom

  • North Tees and Hartlepool NHS Foundation Trust

    Stockton-on-Tees, United Kingdom

  • Northern Lincolnshire and Goole NHS Foundation Trust - Grimsby

    Grimsby, United Kingdom

  • Nottingham University Hospital NHS Trust

    Nottingham, United Kingdom

  • Royal Cornwall Hospitals NHS Trust

    Truro, United Kingdom

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, United Kingdom

  • Sherwood Forest Hospitals NHS Foundation Trust

    Sutton in Ashfield, United Kingdom

  • United Lincolnshire Hospitals NHS Trust - Pilgrim Hospital Boston

    Boston, United Kingdom

  • University Hospital Coventry & Warwickshire

    Coventry, United Kingdom

  • University Hospitals Plymouth NHS Trust

    Plymouth, United Kingdom

  • University Hospitals Sussex NHS Foundation Trust

    Brighton, United Kingdom

  • University Hospitals Sussex NHS Foundation Trust

    Worthing, United Kingdom

  • University Hospitals of Leicester NHS Trust

    Leicester, United Kingdom

  • UniversityHospitals Birmingham NHS Foundation Trust

    Birmingham, United Kingdom

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