Short-course Antibiotics Vs Standard Course Antibiotics in Patients with Cholangitis

Last updated: January 28, 2025
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disorders

Liver Disease

Gall Bladder Disorders

Treatment

cefrtriaxone, gentamicin, cefuroxim, ciprofloxin or other antibiotics according to local guideline (4 to 7 days)

cefrtriaxone, gentamicin, cefuroxim, ciprofloxin or other antibiotics according to local guideline (24 hours)

Clinical Study ID

NCT05750966
2022.0292
NL80410.029.22
2022-002624-12
  • Ages > 18
  • All Genders

Study 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?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with acute cholangitis due to common bile duct stones, benign or malignantdistal biliary obstruction or distal biliary stent dysfunction (only stents in situfor a minimum of 30 days)

  • ERCP with adequate biliary drainage (all common bile duct stones are removed and/orthere 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

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 ofPancreatology/American Pancreatic Association guidelines.[18] Acute pancreatitis isdiagnosed 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 issuspected 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

Study Design

Total Participants: 440
Treatment Group(s): 2
Primary Treatment: cefrtriaxone, gentamicin, cefuroxim, ciprofloxin or other antibiotics according to local guideline (4 to 7 days)
Phase:
Study Start date:
July 19, 2023
Estimated Completion Date:
September 01, 2026

Study Description

Acute cholangitis is an infection of the biliary tract which is managed with biliary drainage and antibiotic therapy (ABT). Currently the international Tokyo Guidelines 2018 (TG18) recommend 4 to 7 days of ABT after source control. The national SWAB guideline of 2020 suggests a course of one to 3 days after biliary drainage. There are no randomized studies to guide the duration of ABT for acute cholangitis. Our recent retrospective study in the Netherlands showed that a short course of ABT seems safe and more evidence is available showing that other bacterial infections, including abdominal and bloodstream infections, can be treated with a short antibiotic course than previously assumed. Hence, the hypothesis is that a very short-course of ABT for acute cholangitis is non-inferior to a course of 4 to 7 days after adequate biliary drainage.

This study is designed as a multicenter non-inferiority randomized controlled trial. Patients will be randomly assigned to the intervention group (one day of antibiotic therapy after ERCP) or the comparator group (4 to 7 days of antibiotic therapy after ERCP).

Connect with a study center

  • Jeroen Bosch Ziekenhuis

    Den Bosch, Brabant 5223 GZ
    Netherlands

    Site Not Available

  • Catharina Ziekenhuis

    Eindhoven, Brabant 5623 EJ
    Netherlands

    Active - Recruiting

  • Elisabeth Tweesteden Ziekenhuis

    Tilburg, Brabant 5022 GC
    Netherlands

    Active - Recruiting

  • Flevoziekenhuis

    Almere, Flevoland 1315 RA
    Netherlands

    Site Not Available

  • Medisch Centrum Leeuwarden

    Leeuwarden, Friesland 8934 AD
    Netherlands

    Site Not Available

  • Rijnstate Ziekenhuis

    Arnhem, Gelderland 6815 AD
    Netherlands

    Site Not Available

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen, Gelderland 6532 SZ
    Netherlands

    Active - Recruiting

  • Radboud umc

    Nijmegen, Gelderland 6525 GA
    Netherlands

    Active - Recruiting

  • Maastricht UMC+

    Maastricht, Limburg 6229 HX
    Netherlands

    Site Not Available

  • Amsterdam UMC

    Amsterdam, Noord Holland 1081 HZ
    Netherlands

    Active - Recruiting

  • Amstelland Ziekenhuis

    Amstelveen, Noord-Holland 1186 AM
    Netherlands

    Site Not Available

  • OLVG

    Amsterdam, Noord-Holland 1091 AC
    Netherlands

    Site Not Available

  • Spaarne Gasthuis

    Hoofddorp, Noord-Holland 2134 TM
    Netherlands

    Site Not Available

  • Dijklander Ziekenhuis

    Hoorn, Noord-Holland 1624 AR
    Netherlands

    Active - Recruiting

  • Zaans Medisch Centrum

    Zaandam, Noord-Holland 1502 DV
    Netherlands

    Site Not Available

  • Deventer Ziekenhuis

    Deventer, Overijssel 7416 SE
    Netherlands

    Site Not Available

  • Medisch Spectrum Twente

    Enschede, Overijssel 7512 KZ
    Netherlands

    Site Not Available

  • Isala

    Zwolle, Overijssel 8025 AB
    Netherlands

    Active - Recruiting

  • Meander MC

    Amersfoort, Utrecht 3813 TZ
    Netherlands

    Site Not Available

  • St. Antonius Ziekenhuis

    Nieuwegein, Utrecht 3435 CM
    Netherlands

    Active - Recruiting

  • Reinier de Graaf Gasthuis

    Delft, Zuid-Holland 2625 AD
    Netherlands

    Site Not Available

  • Haaglanden Medisch Centrum

    Den Haag, Zuid-Holland 2512 VA
    Netherlands

    Site Not Available

  • Albert Schweitzer Ziekenhuis

    Dordrecht, Zuid-Holland 3318 AT
    Netherlands

    Active - Recruiting

  • Groene Hart Ziekenhuis

    Gouda, Zuid-Holland 2803 HH
    Netherlands

    Site Not Available

  • Leids Universitair Medisch Centrum

    Leiden, Zuid-Holland 2333 ZA
    Netherlands

    Site Not Available

  • Alrijne Ziekenhuis

    Leiderdorp, Zuid-Holland 2353 GA
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam, Zuid-Holland 3015 GD
    Netherlands

    Site Not Available

  • Maasstad Ziekenhuis

    Rotterdam, Zuid-Holland 3079 DZ
    Netherlands

    Active - Recruiting

  • Martini Ziekenhuis

    Groningen, 9728 NT
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

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