Abstract
Purpose
Relapse after complicated intra-abdominal infection (cIAI) remains common after treatment. The optimal antibiotic treatment duration for cIAIs is uncertain, especially in cases where source control is not achieved. We hypothesised that in patients with cIAIs, regardless of source control intervention, there would be a lower relapse rate with long-course antibiotics (28 days) compared with short course (≤ 10 days). We piloted a trial comparing ≤ 10-day with 28-day antibiotic treatment for cIAI.
Methods
A randomised controlled unblinded feasibility trial was conducted. Eligible participants were adult patients with a cIAI that were diagnosed ≤ 6 days prior to screening. Randomisation was to long-course (28 days) or short-course (≤10 days) antibiotic therapy. Choice of antibiotics was determined by the clinical team. Participants were followed up for 90 days. Primary outcomes were willingness of participants to be randomised and feasibility of trial procedures.
Results
In total, 172 patients were screened, 84/172 (48.8%) were eligible, and 31/84 (36.9%) were randomised. Patients were assigned to either the short-course arm (18/31, 58.0%) or the long-course arm (13/31, 41.9%). One patient in the short-course arm withdrew after randomisation. In the short-course arm, 4/17 (23.5%) were treated for a cIAI relapse vs 0/13 (0.0%) relapses in the long-course arm. Protocol violations included deviations from protocol-assigned antibiotic duration and interruptions to antibiotic therapy.
Conclusions
This feasibility study identified opportunities to increase recruitment in a full trial. This study demonstrates completion of a randomised controlled trial to further evaluate if the optimum antibiotic duration for cIAIs is feasible.
Trial Registration
ClinicalTrials.gov Identifier: NCT03265834
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Data Availability
The datasets generated and analysed during the current study are available from the corresponding author on reasonable request.
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Acknowledgements
Caroline Bedford, Lead Pharmacist for Clinical Trials, Leeds Teaching Hospitals Trust; Catherine Moriarty, Senior Research Sister, Leeds Teaching Hospitals NHS Trust; Sarah Brown, Medical Statistician, The University of Leeds; Shafaque Shaikh, University of Aberdeen at NHS Grampian.
Funding
Dr. Ahmed was awarded a 1-year clinical research fellowship by Leeds Cares, a charity based at Leeds Teaching Hospitals NHS Trust, UK.
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All authors contributed to the study conception, design, material preparation, data collection and analysis. The first draft of the manuscript was written by Shadia Ahmed, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Informed consent was obtained from all individual participants included in the study.
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Ahmed, S., Brown, R., Pettinger, R. et al. The CABI Trial: an Unblinded Parallel Group Randomised Controlled Feasibility Trial of Long-Course Antibiotic Therapy (28 Days) Compared with Short Course (≤ 10 Days) in the Prevention of Relapse in Adults Treated for Complicated Intra-Abdominal Infection. J Gastrointest Surg 25, 1045–1052 (2021). https://doi.org/10.1007/s11605-020-04545-2
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DOI: https://doi.org/10.1007/s11605-020-04545-2