CompletedPhase 2

CABI: Antibiotic Duration for Complicated Intra-ABdominal Infection

United Kingdom31 participantsStarted 2017-08-01

Plain-language summary

Complicated intra-ABdominal Infections (CABIs) are abdominal infections where there is an abscess inside the abdomen, or a hole (perforation) in an abdominal organ such that infected material e.g. faeces, leaks into the abdominal cavity. A recent review of CABIs after gut surgery found that they can occur in several ways. They can occur in different parts of the abdomen, can be different sizes, and may or may not be caused by a perforated bowel. Management includes, where possible, surgical drainage of an abscess or treatment of the damaged bowel. In addition, all patients are given antibiotic therapy. Despite the varied ways that CABIs occur, we currently tend to treat all CABIs with antibiotics in a similar way. CABIs are associated with significant morbidity and mortality. Despite a significant amount of disease there is little clinical evidence with which to base treatment on. One research study evaluated a short course of antibiotics (4 days) compared with a longer course (up to 10 days) in combination with surgical removal of infection. There was little difference in outcomes, but in both groups about 1 out of every 7 patients had a relapse. A recent review of patients with CABI in Leeds, not in a research study and where surgical removal infection is uncommon and antibiotic durations were short, showed that the risk of relapse was even higher (about 1 in every 3 patients). The antibiotic management of CABIs in the UK is variable and involves giving between 4 days to 28 days of antibiotics. In summary, there is an unacceptably high relapse rate in patients treated for CABI, and uncertainty about the best length of antibiotic therapy that should be used to prevent these relapses. We therefore propose to investigate if long course antibiotic therapy (28 days) is more effective than short course antibiotics (≤10 days) in preventing relapses of CABI.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults \>18 years * The diagnosis of a definite CABI * Capable of giving informed consent * No practical or clinical barriers to consuming 28 days of antibiotic therapy, which may include consumption of antibiotics at home Exclusion Criteria: * a CABI diagnosed within the previous year * a CABI diagnosed \>6 days prior to screening * uncomplicated cholecystitis/cholangitis/gall bladder empyema (no perforation or extra-biliary abscess * a skin and soft tissue infection/abscess not communicating with the peritoneal space * primary complicated or uncomplicated appendicitis managed surgically * intra-abdominal infection associated with pancreatitis, pelvic inflammatory disease, primary (spontaneous) bacterial peritonitis (SBP), continuous ambulatory peritoneal dialysis peritonitis (CAPD peritonitis) and Clostridium difficile infection. concurrent infection requiring more than 10 days of therapy * Infection with a highly resistant bacterium such that antibiotic treatment is considered to be a significantly sub-optimal by the treating microbiologist e.g. multi-resistant carbapenemase producing Entrobacteriacea

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants willing to be randomised, the willingness of clinicians to allow participants to be recruited & follow up rates.

Timeframe: 90 days

Number of participants who have their antibiotic therapy changed as a consequence of allocation to a certain treatment arm.

Timeframe: Either ≤ 10 days or 28 days depending on allocation.

Trial details

NCT IDNCT03265834

SponsorUniversity of Leeds

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-01

View on ClinicalTrials.gov More Complicated Intraabdominal Infections trials