Short-course Antibiotics vs Standard Course Antibiotics in Patients With Cholangitis

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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?

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Ceftriaxone; Cefuroxime; Cefuroxime axetil; Ciprofloxacin; Gentamicins

Criteria

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