Kentaro Iwata1, Asako Doi2, Yuichiro Oba3, Hiroo Matsuo4, Kei Ebisawa5, Manabu Nagata5, Sho Nishimura5, Kenichi Yoshimura6, Atsuhiro Masuda7, Hideyuki Shiomi7, Yuzo Kodama7. 1. Division of Infectious Diseases Therapeutics, Kobe University Graduate School of Medicine, Kusunokicho 7-5-2, Chuoku, Kobe, Hyogo, 650-0017, Japan. kentaroiwata1969@gmail.com. 2. Department of Infectious Diseases, Kobe City Medical Center General Hospital, Minatojimaminamimachi, Chuoku, Kobe, Hyogo, 650-0047, Japan. 3. Department of General Medicine, Osaka General Medical Center, Bandaihigashi 3-1-56, Sumiyoshi, Osaka, 558-8558, Japan. 4. Department of Infectious Diseases, Hyogo Prefectural Amagasaki General Medical Center, Higashinanbacho 2-17-77, Amagasaki, Hyogo, 660-8550, Japan. 5. Division of Infectious Diseases Therapeutics, Kobe University Graduate School of Medicine, Kusunokicho 7-5-2, Chuoku, Kobe, Hyogo, 650-0017, Japan. 6. Innovative Clinical Research Center (iCREK), Kanazawa University Hospital, 13-1 Takara-machi, Kanazawa, Ishikawa, 920-8641, Japan. 7. Department of Gastroenterology, Kobe University Graduate School of Medicine, Kusunokicho 7-5-2, Chuoku, Kobe, Hyogo, 650-0017, Japan.
Abstract
BACKGROUND:Antimicrobial 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/ DESIGN: We 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%. DISCUSSION: This 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 REGISTRATION: University Hospital Medical Information Network, UMIN000028382. Registered on 30 August 2017.
RCT Entities:
BACKGROUND: Antimicrobial 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/ DESIGN: We 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%. DISCUSSION: This 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 REGISTRATION: University Hospital Medical Information Network, UMIN000028382. Registered on 30 August 2017.
Authors: Sylke Haal; Mattheus C B Wielenga; Paul Fockens; Charlotte A Leseman; Cyriel Y Ponsioen; Ellert J van Soest; Roy L J van Wanrooij; Elske Sieswerda; Rogier P Voermans Journal: Dig Dis Sci Date: 2021-01-19 Impact factor: 3.199