Overview

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