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

Status: Recruiting
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Netherlands
Jeroen Bosch Ziekenhuis
NOT_YET_RECRUITING
's-hertogenbosch
Flevoziekenhuis
NOT_YET_RECRUITING
Almere Stad
Meander MC
NOT_YET_RECRUITING
Amersfoort
Amstelland Ziekenhuis
NOT_YET_RECRUITING
Amstelveen
Amsterdam UMC
RECRUITING
Amsterdam
OLVG
NOT_YET_RECRUITING
Amsterdam
Rijnstate Ziekenhuis
NOT_YET_RECRUITING
Arnhem
Reinier de Graaf Gasthuis
NOT_YET_RECRUITING
Delft
Deventer Ziekenhuis
NOT_YET_RECRUITING
Deventer
Albert Schweitzer Ziekenhuis
RECRUITING
Dordrecht
Catharina Ziekenhuis
RECRUITING
Eindhoven
Medisch Spectrum Twente
NOT_YET_RECRUITING
Enschede
Groene Hart Ziekenhuis
NOT_YET_RECRUITING
Gouda
Martini Ziekenhuis
NOT_YET_RECRUITING
Groningen
Universitair Medisch Centrum Groningen
RECRUITING
Groningen
Spaarne Gasthuis
NOT_YET_RECRUITING
Hoofddorp
Dijklander Ziekenhuis
RECRUITING
Hoorn
Medisch Centrum Leeuwarden
NOT_YET_RECRUITING
Leeuwarden
Leids Universitair Medisch Centrum
NOT_YET_RECRUITING
Leiden
Alrijne Ziekenhuis
NOT_YET_RECRUITING
Leiderdorp
Maastricht UMC+
NOT_YET_RECRUITING
Maastricht
St. Antonius Ziekenhuis
RECRUITING
Nieuwegein
Canisius Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Radboud umc
RECRUITING
Nijmegen
Erasmus MC
NOT_YET_RECRUITING
Rotterdam
Maasstad Ziekenhuis
RECRUITING
Rotterdam
Haaglanden Medisch Centrum
NOT_YET_RECRUITING
The Hague
Elisabeth Tweesteden Ziekenhuis
RECRUITING
Tilburg
Universitair Medisch Centrum Utrecht
NOT_YET_RECRUITING
Utrecht
Zaans Medisch Centrum
NOT_YET_RECRUITING
Zaandam
Isala
RECRUITING
Zwolle
Time Frame
Start Date: 2023-07-19
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 440
Treatments
Experimental: Very short-course antibiotics
The antibiotic regimens will be according to the local hospital's antibiotic guideline for cholangitis (e.g. dosage form, dosage, frequency)and/or the national SWAB guideline in the Netherlands. In the experimental group, duration of ABT after adequate drainage will be 1 day. The duration will be 4 days and can be extended to 7 days in case of gram-negative bacteraemia, according to the national SWAB guideline regarding gram-negative sepsis.
Active_comparator: Standard course antibiotics
The antibiotic regimens will be according to the local hospital's antibiotic guideline for cholangitis, which are based on the previously mentioned national SWAB guideline. This means that the type of ABT, dosage and frequency will be comparable to the experimental group.~In the comparator group treatment duration with ABT after ERCP will be according to the international well known and widely used TG18. The duration will be 4 days and can be extended to 7 days in case of gram-negative bacteraemia, according to the national SWAB guideline regarding gram-negative sepsis.
Related Therapeutic Areas
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development

This content was sourced from clinicaltrials.gov