CompletedNot Applicable

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

Netherlands410 participantsStarted 2023-07-19

Plain-language 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?

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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-reacti…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

clinical cure rate by day 14 after ERCP without relapse by day 30

Timeframe: 30 days

Trial details

NCT IDNCT05750966

SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-01

View on ClinicalTrials.gov More Cholangitis trials