CABI试验：一项非盲平行组随机对照可行性试验，比较长疗程抗生素治疗（28天）与短疗程（≤10天）在预防复杂性腹腔内感染成人患者复发方面的效果

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.

作者信息

Ahmed Shadia, Brown Rory, Pettinger Richard, Vargas-Palacios Armando, Burke Dermot, Kirby Andrew

机构信息

Microbiology Department, Old Medical School, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds, LS1 3EX, UK.

University of Leeds, Leeds, LS3 1EX, UK.

出版信息

J Gastrointest Surg. 2021 Apr;25(4):1045-1052. doi: 10.1007/s11605-020-04545-2. Epub 2020 Mar 5.

DOI:10.1007/s11605-020-04545-2

PMID:32140989

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.

摘要

目的

复杂性腹腔内感染（cIAI）治疗后复发仍然常见。cIAI的最佳抗生素治疗时长尚不确定，尤其是在未实现源头控制的情况下。我们假设，对于cIAI患者，无论源头控制干预情况如何，与短疗程（≤10天）相比，长疗程抗生素治疗（28天）的复发率会更低。我们开展了一项试验，比较cIAI患者接受≤10天与28天抗生素治疗的效果。

方法

进行了一项随机对照非盲可行性试验。符合条件的参与者为在筛查前≤6天被诊断为cIAI的成年患者。随机分为长疗程（28天）或短疗程（≤10天）抗生素治疗。抗生素的选择由临床团队决定。对参与者进行90天的随访。主要结局是参与者的随机分组意愿和试验程序的可行性。

结果

共筛查了172例患者，84/172（48.8%）符合条件，31/84（36.9%）被随机分组。患者被分配到短疗程组（18/31，58.0%）或长疗程组（13/31，41.9%）。短疗程组中有1例患者在随机分组后退出。在短疗程组中，4/17（23.5%）因cIAI复发接受治疗，而长疗程组中复发率为0/13（0.0%）。方案违规包括偏离方案指定的抗生素疗程和抗生素治疗中断。