A Phase 2 interventional study of < 10 days of antibiotics and 28 days of antibiotics in Complicated Intraabdominal Infections, sponsored by University of Leeds. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-03.
Sponsored by University of Leeds · Phase 2, Interventional, and Treatment
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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.
Complicated intra-abdominal infection (CABI) extends beyond the hollow viscus of origin into the peritoneal space and is associated with either abscess formation or peritonitis [Solomkin 2010]. CABIs are heterogeneous in aetiology and include spontaneous infections arising from a perforated viscus, including the stomach, biliary tree, colon, appendix and reproductive organs. In addition there are post-operative complications such as peritonitis, abscess, and failure of surgical anastomoses. CABIs are also heterogeneous in their characteristics. A recent review of organ space Surgical Site Infections (SSI-Os) after colorectal surgery demonstrated that infections were varied with regard their location, as well as size and number and nature of collections, and presence of an ongoing source e.g. anastomotic breakdown (Rothwell 2016). Despite the varied origin of these infections, there are similar management strategies which centre on the source control, e.g. drainage of intra-abdominal fluid collections, and administration of antibiotic therapy. CABIs are a common in-hospital clinical challenge, in part due to the varied pathology they are caused by, and are associated with significant morbidity and mortality (DeFrances 2005, Brun-Buisson 1995). Despite this burden of disease, there is little clinical evidence with which to base treatment on, even before taking account of their heterogeneous nature. One study of CABI following source control procedures evaluated a short course of antibiotics (4 days) compared to a course of up to 2 weeks after clinical and biochemical improvement (up to 10 days). Whilst there was little difference in outcomes, both groups had a high relapse rate of approximately 15%. In addition, it is common for source control procedures not to be completed in routine clinical practice, being completed in only 17% of Leeds patients with post-operative CABI (Rothwell 2016). In this Leeds data of post-operative CABIs, where source control rates are low relapse rates were 40% (Rothwell 2016). For CABI infections, standard UK management is variable and involves between 4 and 42 days' antibiotics. This indicates an unacceptably high relapse rate in patients treated for CABI where source control is and is not undertaken. We therefore propose to investigate if long course antibiotic therapy (28 days) is clinically more effective than short course antibiotics (4 days) in preventing relapses of CABI. This study will include patients who have and have not undergone source control procedures which will be completed as per standard practice.
Complicated intra-abdominal infections require source control when possible, e.g. a surgical procedure to remove an infection, and antibiotic therapy to obtain cure. Source control is not always possible. CABIs are associated with mortality and prolongation of hospitalisation. After apparently effective treatment, potentially including source control procedures and antibiotics, infections can relapse. There are a number of reasons for relapse; one is that antibiotic treatment may not have been given for long enough to eradicate the bacteria from, what should be, a sterile intra-abdominal cavity. Antibiotics are given until a patient is better, but not until all bacteria are eradicated, allowing them to regrow and re-start an infection. Standard antibiotic duration is variable: some doctors provide long courses and others short. We therefore want to compare durations, to see if longer courses of antibiotics are able to help prevent these relapses, or if shorter courses are as effective but have fewer side effects. We have not identified closely related strategies which may optimise the management of CABIs.
The research hypothesis is therefore: In patients with CABI, regardless of source control intervention, there will be a lower relapse rate when treated with 28 days of antibiotics compared to ≤10 days of antibiotics.
129 studies on the registry are indexed under Intraabdominal Infections; 15 are open to participants now.
This study's enrollment of 31 is below the median of 140 across 77 interventional studies indexed under Intraabdominal Infections.
Browse Intraabdominal Infections studies →University of Leeds is the lead sponsor of 206 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Antibiotic therapy for a duration of 28 days
Other: 28 days of antibiotics
Antibiotic therapy for a duration of ≤10 days
Other: < 10 days of antibiotics
Antibiotic duration
Antibiotic duration
Number of participants willing to be randomised, the willingness of clinicians to allow participants to be recruited & follow up rates.
Screening logs, recruitment rates and follow up rates will be recorded to determine the feasibility of performing a larger study.
Time frame: 90 days
Number of participants who have their antibiotic therapy changed as a consequence of allocation to a certain treatment arm.
Antibiotic therapy received including any changes to treatment will be recorded.
Time frame: Either ≤ 10 days or 28 days depending on allocation.
The number of participants who relapse after treatment of complicated intra-abdominal infection.
Frequency of complicated intra-abdominal infection (CABI) relapse with 90 days. A relapse can only occur after surgical and antibiotic therapy to manage the primary CABI has been considered successful. This will normally be demonstrated by antibiotics being stopped and no further source control procedures planned. The diagnosis of a definite CABI relapse defined as 'a combination of radiological AND clinical features consistent with CABI including a fluid collection, a temperature of ≥38 degrees and a neutrophilia (neutrophil count \> 7.5 x 10\*9/L) or Intra-operative confirmation of an abscess'. The diagnosis of a probable CABI relapse will be defined as ' in the absence of radiological imaging, but where no other source of infection was identified, and the patient was managed for a relapsed CABI'
Time frame: 90 days
Number of all infections after treatment of complicated intra-abdominal infection
The diagnosis of hospital acquired infections will be based on either a clinical diagnosis based on physician assessment or on definitions outlined by the 'Point prevalence survey of healthcare-associated infections and antimicrobial use in European acute-care hospitals' https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/542039/ECDC_PHE_HAI_AU_PPS_2016_single_codebook.pdf
Time frame: 90 days
Total antibiotic consumption
Days of antibiotic therapy within 90 days of antibiotic therapy
Time frame: 90 days
Length of hospital stay within 90 days of diagnosis
The length of hospital stay after diagnosis of complicated intra-abdominal infection
Time frame: 90 days
Mortality rate after treatment of complicated intra-abdominal infection.
Assessed by the 90 day mortality after diagnosis of a complicated intra-abdominal infection.
Time frame: 90 days
The number of participants with complications from antibiotic therapy including Clostridium difficile infection (CDI) diarrhoea and catheter related blood stream infection (CRBSI)
Measured by the rate of adverse events, CDI and CRBSI within 90 days of diagnosis.
Time frame: 90 days
The number of source control procedures required for the management of CABI
Measured by the number source control procedures required for the management of CABI within 90 days of CABI diagnosis.
Time frame: 90 days
Quality of life after treatment of complicated intra-abdominal infection
Assessed by a quality of life questionnaire (EQ-5D)
Time frame: Baseline, at 30 days, at 90 days and (if occurs) at time of relapse
Feasibility of using scoring systems in complicated intra-abdominal infections
Measured by the ability to gather the data required to complete severity scores
Time frame: 90 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2017 to primary completion in Sep 2018, 13 months.
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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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