Actively Recruiting
EXTENDed Antibiotic Durations Compared to Standard Durations for Patients With Complicated Intra-abdominal Infection.
Led by Sarah Cockayne · Updated on 2024-12-24
1166
Participants Needed
36
Research Sites
168 weeks
Total Duration
On this page
Sponsors
S
Sarah Cockayne
Lead Sponsor
U
University of York
Collaborating Sponsor
AI-Summary
What this Trial Is About
A multicentre, open label, two-arm, parallel group, pragmatic, randomised controlled trial with internal pilot. A total of 1166 consenting adult patients with cIAI will be recruited and randomised on a 1:1 basis between 28-days antibiotics and standard care antibiotics. Patients will be followed up for 180 days to determine cost effectiveness and the rate of treatment failure in each group.
CONDITIONS
Official 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 receiving antibiotics for cIAI within 10 days of starting effective antibiotic treatment
- Able to provide informed consent or have a consultee to provide consent
- Require more than 72 hours of active inpatient management for cIAI
- Likely to be admitted to a participating hospital if readmitted during the trial
- Inclusion regardless of undergoing surgical or radiological source control procedures
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 confirmed by CT
- Grade 1 to 3 appendicitis; only Grade 4 or 5 appendicitis with generalized peritonitis or partial/no source control eligible
- Non-perforated cholecystitis
- Ischemic or necrotic intestine without perforation
- Uterine perforation treated within six hours of injury
- Patients with cIAI considered low risk requiring more than 72 hours antibiotics
- Enrollment in another trial dictating antibiotic duration
- Previous Clostridium difficile infection
- Infected necrotic pancreatitis
- Concomitant infections requiring 4 or more weeks of antibiotics
- Peritoneal dialysis
- Previous participation in the EXTEND trial
- Treatment with Interleukin-6 inhibitors
- High likelihood of death within 72 hours of randomization
- Pre-existing treatment limitations expecting patient death
- Persistent cIAI lasting more than 6 months
- Maximum of 20% of participants with appendix as infection source; exceeding this will exclude additional appendix cases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
P
Puvan Tharmanathan, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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