EXTENDed Antibiotic Durations Compared to Standard Durations for Patients With Complicated Intra-abdominal Infection.
This study, called EXTEND, is looking at the best way to treat complicated infections inside the tummy. These infections can sometimes come back or lead to other problems. Usually, patients receive antibiotics for a 'standard' amount of time, which can vary. This study wants to find out if giving antibiotics for a fixed, longer period of 28 days is more effective than the usual shorter courses (typically 7-18 days). Researchers will compare how well patients recover, their quality of life, and the cost-effectiveness of each approach over six months. The goal is to provide the best possible care for patients and help reduce the risk of infections returning or new ones developing.
At a glance
What is this study about?
When you have a serious infection inside your tummy, sometimes called a complicated intra-abdominal infection, you'll be given antibiotics. Doctors usually try to give antibiotics for the shortest time possible to fight against antibiotic resistance – when antibiotics stop working. However, if a short course means your infection comes back and you end up back in hospital, then perhaps a slightly longer course could be better for you in the long run.
This study, called EXTEND, is trying to answer that question. It looks at whether a fixed course of 28 days of antibiotics is better than the usual shorter course you might receive (which typically lasts 7 to 18 days). The main aim is to see if longer treatment leads to better recovery, fewer further infections, and generally improves your quality of life over six months. They will also look at whether a longer course offers good value for money for the NHS.
The study will involve over a thousand adults across about 30 NHS hospitals. Half of the patients will receive their antibiotics for the usual amount of time, decided by their doctor. The other half will receive antibiotics for a fixed 28-day period. Crucially, the type of antibiotic will still be chosen by your doctor – it's just the length of time you take them that will be different.
Key takeaways
- Compares standard vs. 28-day antibiotic courses for serious tummy infections.
- Aims to improve patient recovery and quality of life.
- Over 1000 adults will take part across many NHS hospitals.
- Participation involves questionnaires and hospital record review.
- You can leave the study at any time.
- The study follows patients for 6 months to assess long-term outcomes.
Who may be eligible?
You might be able to join this study if you are an adult, aged 16 or over, and have a complicated infection inside your tummy. You would need to be receiving antibiotics for this infection, and it must be within 10 days of when your effective antibiotic treatment started. You should also have spent at least 72 hours under hospital care for your infection.
It's important that you (or someone who can speak for you) are able to understand the study and agree to take part. The study also needs to make sure that if you were to be readmitted to hospital during the study period, it would likely be one of the hospitals taking part in the EXTEND trial.
Whether you need surgery or another procedure for your infection doesn't usually affect your eligibility to join. However, antibiotics given for other reasons – like preventing infection, or for a different type of infection like a simple urine infection – would not count towards the treatment time for this study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 16 years old or older?
- Do you have a serious infection inside your tummy (complicated intra-abdominal infection)?
- Have you been on effective antibiotics for this infection for 10 days or less?
- Have you been in hospital for your infection for at least 3 days (72 hours)?
- Can you, or someone on your behalf, give consent to participate?
- If readmitted, would it likely be to a participating hospital?
What does participation involve?
If you join the study, you'll be randomly put into one of two groups. One group will receive their antibiotics for the usual length of time, as decided by their doctor. The other group will receive their antibiotics for a continuous 28-day period. The type of antibiotic will always be chosen by your doctor based on what's best for you.
Throughout the study, you'll be asked to complete some questionnaires about your quality of life, your antibiotic use, and any healthcare you receive. These questionnaires will be filled out when you start the study, and then again after 30, 60, and 180 days (about 6 months). The study team will also look at your hospital notes to see details like whether you were admitted to hospital again or developed further infections. The total follow-up period for the study is 180 days from when you join.
Potential risks and benefits
Locations (36)
- Cwm Taf Morgannwg University Health Board,Verified postcodeAbercynon, United Kingdom· Recruiting
- NHS GrampianVerified postcodeAberdeen, United Kingdom· Recruiting
- Hywel Dda University Health BoardVerified postcodeAberystwyth, United Kingdom· Recruiting
- Buckinghamshire Healthcare NHS TrustVerified postcodeAylesbury, United Kingdom· Recruiting
- UniversityHospitals Birmingham NHS Foundation TrustVerified postcodeBirmingham, United Kingdom· Recruiting
- Bolton NHS Foundation TrustVerified postcodeBolton, United Kingdom· Recruiting
- United Lincolnshire Hospitals NHS Trust - Pilgrim Hospital BostonVerified postcodeBoston, United Kingdom· Recruiting
- University Hospitals Sussex NHS Foundation TrustVerified postcodeBrighton, United Kingdom· Recruiting
- North Bristol NHS TrustVerified postcodeBristol, United Kingdom· Not yet recruiting
- North Cumbria Integrated Care NHS Foundation TurstVerified postcodeCarlisle, United Kingdom· Recruiting
- Chesterfield Royal Hospital NHS Foundation TrustVerified postcodeChesterfield, United Kingdom· Recruiting
- University Hospital Coventry & WarwickshireVerified postcodeCoventry, United Kingdom· Recruiting
Common questions
What is a 'complicated intra-abdominal infection'?
This is a serious infection inside your tummy that might involve organs like your bowel or stomach, often needing hospital treatment. You might have a fever, high white blood cell count, or signs of infection visible on scans.
Why 28 days of antibiotics?
The study wants to see if a longer, fixed course of antibiotics (28 days) helps patients recover better and prevents infections from coming back compared to the usual variable shorter courses.
Will I know which treatment group I'm in?
Yes, this is an 'open label' study, meaning both you and your doctors will know whether you are receiving the standard duration or the fixed 28-day course of antibiotics once you've been assigned.
What does 'randomised' mean?
Randomised means you have an equal, chance-based possibility of being assigned to either the standard antibiotic duration group or the extended 28-day antibiotic duration group, much like flipping a coin.
Who is sponsoring this study?
The University of Leeds is sponsoring this study, meaning they are responsible for its management and oversight.
How to find out more
Sarah Cockayne
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.