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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 7 to 28 days depending on treatment arm

Participants receive antibiotic treatment for complicated intra-abdominal infection with duration determined by randomization to either standard care or a fixed extended duration of 28 days.

Visits as part of routine hospital care during antibiotic treatment

Follow-up

Duration - Up to 180 days after randomization

Participants complete quality of life and antibiotic use questionnaires and are monitored for treatment outcomes including relapse and complications.

Questionnaire assessments at baseline, 30, 60, and 180 days post-randomization

Trial Site Locations

Total: 36 locations

1

Cwm Taf Morgannwg University Health Board,

Abercynon, United Kingdom

Actively Recruiting

2

NHS Grampian

Aberdeen, United Kingdom

Actively Recruiting

3

Hywel Dda University Health Board

Aberystwyth, United Kingdom

Actively Recruiting

4

Buckinghamshire Healthcare NHS Trust

Aylesbury, United Kingdom

Actively Recruiting

5

UniversityHospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Actively Recruiting

6

Bolton NHS Foundation Trust

Bolton, United Kingdom

Actively Recruiting

7

United Lincolnshire Hospitals NHS Trust - Pilgrim Hospital Boston

Boston, United Kingdom

Actively Recruiting

8

University Hospitals Sussex NHS Foundation Trust

Brighton, United Kingdom

Actively Recruiting

9

North Bristol NHS Trust

Bristol, United Kingdom

Not Yet Recruiting

10

North Cumbria Integrated Care NHS Foundation Turst

Carlisle, United Kingdom

Actively Recruiting

11

Chesterfield Royal Hospital NHS Foundation Trust

Chesterfield, United Kingdom

Actively Recruiting

12

University Hospital Coventry & Warwickshire

Coventry, United Kingdom

Actively Recruiting

13

County Durham and Darlington NHS Foundation Trust

Darlington, United Kingdom

Actively Recruiting

14

Northern Lincolnshire and Goole NHS Foundation Trust - Grimsby

Grimsby, United Kingdom

Actively Recruiting

15

Hull University Teaching Hospitals NHS Trust

Hull, United Kingdom

Actively Recruiting

16

East Suffolk and North Essex NHS Foundation Trust

Ipswich, United Kingdom

Actively Recruiting

17

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Actively Recruiting

18

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Actively Recruiting

19

Chelsea and Westminster Hospital NHS Foundation Trust

London, United Kingdom

Actively Recruiting

20

Guys and St Thomas' NHS Foundation Trust

London, United Kingdom

Actively Recruiting

21

Imperial College Healthcare NHS Trust

London, United Kingdom

Actively Recruiting

22

King'S College Hospital Nhs Foundation Trust

London, United Kingdom

Actively Recruiting

23

East Cheshire NHS Trust

Macclesfield, United Kingdom

Actively Recruiting

24

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Actively Recruiting

25

Aneurin Bevan University Health Board

Newport, United Kingdom

Active, Not Recruiting

26

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, United Kingdom

Actively Recruiting

27

Nottingham University Hospital NHS Trust

Nottingham, United Kingdom

Actively Recruiting

28

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Actively Recruiting

29

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, United Kingdom

Actively Recruiting

30

Barking, Havering and Redbridge University Hospitals Nhs Trust

Romford, United Kingdom

Actively Recruiting

31

East Sussex Hospitals NHS Trust

Saint Leonards-on-Sea, United Kingdom

Actively Recruiting

32

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

Actively Recruiting

33

North Tees and Hartlepool NHS Foundation Trust

Stockton-on-Tees, United Kingdom

Actively Recruiting

34

Sherwood Forest Hospitals NHS Foundation Trust

Sutton in Ashfield, United Kingdom

Actively Recruiting

35

Royal Cornwall Hospitals NHS Trust

Truro, United Kingdom

Actively Recruiting

36

University Hospitals Sussex NHS Foundation Trust

Worthing, United Kingdom

Actively Recruiting

Loading map...

Research Team

S

Sarah Cockayne

P

Puvan Tharmanathan, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Prospective Observational Post Marketing Surveillance Study ...

Complicated Intra-abdominal Infection

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here