Abstract
BackgroundAntimicrobial therapy with appropriate biliary drainage is considered the standard of care for acute cholangitis, but the optimal duration of antimicrobial therapy remains unknown. Seven to 10 days of antimicrobial therapy are common for the treatment of acute cholangitis, but a recent retrospective cohort study suggested a shorter duration might be effective. A shorter duration of antimicrobial therapy can be beneficial in decreasing the length of hospital stay, improving patients’ quality of life, decreasing adverse effects, and even contributing to a decrease in the occurrence of antimicrobial resistance.Methods/designWe will conduct a multi-centre, open-label, randomized, non-inferiority trial to compare short-course therapy (SCT) with conventional long-course therapy (LCT) in treating patients with acute cholangitis. SCT consists of 5-day intravenous antimicrobial therapy if the patients had clinical improvement, while at least 7 days of intravenous antibiotics will be provided to the LCT group. The primary outcome is clinical cure at 30 days after onset. Patients will be randomly assigned in an open-label fashion. A total sample size of 150 was estimated to provide a power of 80% with a one-sided α level of 2.5% and a non-inferiority margin of 10%.DiscussionThis trial is expected to reveal whether SCT is non-inferior to conventional LCT or not, and may provide evidence that one can shorten the treatment duration for acute cholangitis for the benefit of patients.Trial registrationUniversity Hospital Medical Information Network, UMIN000028382. Registered on 30 August 2017.
Highlights
Antimicrobial therapy with appropriate biliary drainage is considered the standard of care for acute cholangitis, but the optimal duration of antimicrobial therapy remains unknown
This trial is expected to reveal whether short-course therapy (SCT) is non-inferior to conventional long-course therapy (LCT) or not, and may provide evidence that one can shorten the treatment duration for acute cholangitis for the benefit of patients
In the SCT group, positive blood culture results will not alter the duration of the treatment unless other complications which necessitate prolongation of the treatment, such as abscess or infective endocarditis, occur and either the treating physicians or the consultant infectious disease doctors remove the patient from the intervention
Summary
The current trial will examine whether SCT for acute cholangitis with appropriate biliary duct drainage is not inferior to conventional LCT. For practical reasons, we were not able to design the study to be double-blinded. Both patients and investigators will know to which group the patients belong. We consider that the outcomes we set are obvious and would not be likely to be impaired significantly by the trial being an open-label design, as demonstrated in a previous similar study [14]. The results of the proposed study are not applicable to those patients with acute cholangitis when bile duct obstruction remains. The trial is scheduled to end on December 31, 2021
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