EXTENDed antibiotic durations for abdominal infections v1.0
Research type
Research Study
Full title
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 - a phase III multicentre, open label, two-arm, parallel group, pragmatic, randomised controlled trial with internal pilot.
IRAS ID
302989
Contact name
Andrew Kirby
Contact email
Sponsor organisation
University of Leeds
ISRCTN Number
ISRCTN72819021
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 6 months, 0 days
Research summary
Bacteria live in the intestine to help digest food. If the intestine is damaged by an operation, injury or a disease such as cancer, bacteria can leak into the space surrounding the intestine (called the abdominal cavity) and cause serious infections. Over thirty thousand patients per year suffer this infection.
The care of patients with abdominal cavity infections is a big concern for doctors. The damaged area of the intestine may need to be removed by surgery. Antibiotics are used to kill any bacteria left in the abdominal cavity. Sometimes this treatment does not work very well. In up to half of patients the original infection comes back or patients develop another infection. These patients may need a second round of treatment. This might include antibiotics or an operation.
Research from other trials has suggested that longer courses of antibiotics may offer benefits for patients with serious abdominal infections. If longer courses of antibiotics are better at curing and preventing infections, they may be better at keeping patients out of hospital. This may reduce the chance patients will catch antibiotic resistant infections.
We would like to find out if longer antibiotic courses are better for patients with abdominal cavity infections. The EXTEND trial will group patients by chance into one of two treatment groups. One group will take antibiotics for between 7 to 18 days. This will be decided by their own care team. The other group will take antibiotics for 28 days. We will monitor patients in both groups over six months to see whether the treatments prevent return of the original infection and stop the development of new infections.
The results of the research will be shared throughout the NHS and charities to help doctors decide if longer courses of antibiotics will benefit patients with abdominal cavity infections.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
22/YH/0023
Date of REC Opinion
10 Mar 2022
REC opinion
Further Information Favourable Opinion