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Comparing short and standard antibiotic courses for cholangitis treatment

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

Not applicable Interventional Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT05750966

This study is testing if a one-day course of antibiotics is just as effective as the usual 4 to 7-day course for treating cholangitis after a procedure to clear the bile ducts.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment440 (estimated)
Ages18 Years and up
SexAll
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other
Locations31 sites (Den Bosch, Brabant and 30 other locations)
Trial IDNCT05750966 on ClinicalTrials.gov

What this trial studies

This multicenter randomized controlled trial aims to determine if a one-day course of antibiotics is as effective as the standard 4 to 7-day course for treating cholangitis after adequate drainage. The study will assess clinical cure rates, relapse, mortality, adverse drug events, length of hospital stay, quality of life, and cost-effectiveness. Patients will be randomly assigned to receive either the short or standard antibiotic regimen following endoscopic retrograde cholangiopancreatography (ERCP). The findings could provide new insights into antibiotic duration for cholangitis management.

Who should consider this trial

Good fit: Ideal candidates include adults with acute cholangitis due to specific causes who have undergone successful biliary drainage.

Not a fit: Patients with other causes of cholangitis, recurrent cholangitis, or those with surgically altered anatomy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to shorter antibiotic treatments for cholangitis, reducing hospital stays and adverse effects for patients.

How similar studies have performed: While similar studies on short antibiotic courses for other infections have shown promise, this specific approach for cholangitis is novel and untested.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Den Bosch, Brabant and 30 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cholangitisantibioticsrandomized controlled trial
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.