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ACTIVE NOT RECRUITING
NCT05750966
NA

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

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

View on ClinicalTrials.gov

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?

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

440

Start Date

2023-07-19

Completion Date

2026-09-01

Last Updated

2026-02-05

Healthy Volunteers

No

Conditions

Interventions

DRUG

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

The duration of antibiotics is 24 hours after adequate biliary drainage. The choice of antibiotics will be according to local protocol and/or national Dutch SWAB guidelines. The most common antibiotics are described above, but this can differ based on allergies, local protocol or previous cultures. Drug classes may include: aminoglycosides, carbapenems, cefalosporins, fluorquinolones, sulfonamides, penicillines.

DRUG

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

The duration of antibiotics is 4 to 7 days after adequate biliary drainage. The choice of antibiotics will be according to local protocol and/or national Dutch SWAB guidelines. The most common antibiotics are described above, but this can differ based on allergies, local protocol or previous cultures. Drug classes may include: aminoglycosides, carbapenems, cefalosporins, fluorquinolones, sulfonamides, penicillines.

Locations (31)

Flevoziekenhuis

Almere Stad, Flevoland, Netherlands

Rijnstate Ziekenhuis

Arnhem, Gelderland, Netherlands

Radboud umc

Nijmegen, Gelderland, Netherlands

Canisius Wilhelmina Ziekenhuis

Nijmegen, Gelderland, Netherlands

Maastricht UMC+

Maastricht, Limburg, Netherlands

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, Netherlands

Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

Elisabeth Tweesteden Ziekenhuis

Tilburg, North Brabant, Netherlands

Amstelland Ziekenhuis

Amstelveen, North Holland, Netherlands

Amsterdam UMC

Amsterdam, North Holland, Netherlands

OLVG

Amsterdam, North Holland, Netherlands

Spaarne Gasthuis

Hoofddorp, North Holland, Netherlands

Dijklander Ziekenhuis

Hoorn, North Holland, Netherlands

Zaans Medisch Centrum

Zaandam, North Holland, Netherlands

Deventer Ziekenhuis

Deventer, Overijssel, Netherlands

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

Isala

Zwolle, Overijssel, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

Reinier de Graaf Gasthuis

Delft, South Holland, Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, South Holland, Netherlands

Groene Hart Ziekenhuis

Gouda, South Holland, Netherlands

Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

Alrijne Ziekenhuis

Leiderdorp, South Holland, Netherlands

Erasmus MC

Rotterdam, South Holland, Netherlands

Maasstad Ziekenhuis

Rotterdam, South Holland, Netherlands

Haaglanden Medisch Centrum

The Hague, South Holland, Netherlands

Meander MC

Amersfoort, Utrecht, Netherlands

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Martini Ziekenhuis

Groningen, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands