Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
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