Very Short-course Versus Standard Course Antibiotic Therapy in Patients With Acute ChOlangitis After Adequate Endoscopic BiliaRy drAinage

2022.0292

The goal of this multicentre randomized controlled trial is to investigate if a very short-course of antibiotics (1 day) for cholangitis after adequate drainage is non-inferior with respect to clinical cure in comparison with a standard course of antibiotics (4 to 7 days). Secondary objectives include: * Will a one-day course of antibiotics for cholangitis after adequate drainage be non-inferior with respect to relapse of cholangitis and mortality in comparison with a standard course of antibiotics? * Will a one-day course of antibiotics for cholangitis after adequate drainage result in less adverse drug events in comparison with a standard course of antibiotics? * Will a one-day course of antibiotics for cholangitis after adequate drainage reduce length of hospital stay? * Will a one-day course of antibiotics for cholangitis after adequate drainage improve quality of life? * Will a one-day course of antibiotics for cholangitis after adequate drainage be cost-effective?

2023-07-19

2026-03-01

2026-09-01

Recruiting

440

Inclusion Criteria: * Patients with acute cholangitis due to common bile duct stones, benign or malignant distal biliary obstruction or distal biliary stent dysfunction (only stents in situ for a minimum of 30 days) * ERCP with adequate biliary drainage (all common bile duct stones are removed and/or there is adequate flow of clear bile with or without a biliary stent(s)) * Absence of fever (temperature \<38.5°C) or a decrease of body temperature of at least 1°C has occurred within 24 hours after ERCP * Age ≥ 18 years * Written informed consent (IC) Exclusion Criteria: * Other aetiologies of acute cholangitis (e.g. primary sclerosing cholangitis, (sub)hilar and/or intrahepatic strictures or hilar stents) * A recurrent cholangitis (within 3 months) * Patients with surgically altered anatomy (leading to biliary-enteric anastomosis) * Concomitant pancreatitis, according to International Association of Pancreatology/American Pancreatic Association guidelines.\[18\] Acute pancreatitis is diagnosed in case of fulfilment of 2 out of 3 of the following criteria: * Upper abdominal pain * Serum amylase or lipase \>3x ULN * Signs of acute pancreatitis on imaging * Concomitant cholecystitis, according to TG18 criteria.\[19\] Acute cholecystitis is suspected in case one item in A is met and one item in B and C. A. Local signs of inflammation * A1: Murphy's sign * A2: Right upper quadrant mass/pain/tenderness B. Systemic signs of inflammation * B1: Fever * B2: Elevated C-reactive protein * B3: Elevated WBC count C. Imaging findings characteristic of acute cholecystitis * Concomitant liver abscess * Another additional infectious diagnosis * Admission on an Intensive Care Unit (ICU) at time of randomisation * Use of maintenance antimicrobial therapy * Use of immunosuppressants * Neutropenia

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is designed as an open-label multicenter non-inferiority RCT. Patients will be randomly assigned to the intervention group (one day of ABT after ERCP) or the comparator group (4 to 7 days of ABT after ERCP).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Patients and investigators will know in which group they are assigned.'}}, 'enrollmentInfo': {'count': 440, 'type': 'ESTIMATED'}}

2023-07-20