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Short-course Antibiotics vs Standard Course Antibiotics in Patients With Cholangitis
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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
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.
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