Back to resultsShort-course Antibiotics vs Standard Course Antibiotics in Patients With Cholangitis (COBRA)
Primary Purpose
Cholangitis
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
cefrtriaxone, gentamicin, cefuroxim, ciprofloxin or other antibiotics according to local guideline (24 hours)
cefrtriaxone, gentamicin, cefuroxim, ciprofloxin or other antibiotics according to local guideline (4 to 7 days)
Sponsored by
About this trial
This is an interventional treatment trial for Cholangitis focused on measuring antibiotics, randomized controlled trial
Eligibility 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
Sites / Locations
- Jeroen Bosch Ziekenhuis
- Catharina ZiekenhuisRecruiting
- Elisabeth Tweesteden ZiekenhuisRecruiting
- Flevoziekenhuis
- Medisch Centrum Leeuwarden
- Rijnstate Ziekenhuis
- Radboud umcRecruiting
- Canisius Wilhelmina ZiekenhuisRecruiting
- Maastricht UMC+
- Amsterdam UMCRecruiting
- Amstelland Ziekenhuis
- OLVG
- Spaarne Gasthuis
- Dijklander ZiekenhuisRecruiting
- Zaans Medisch Centrum
- Deventer Ziekenhuis
- Medisch Spectrum Twente
- IsalaRecruiting
- Meander MC
- St. Antonius ZiekenhuisRecruiting
- Reinier de Graaf Gasthuis
- Haaglanden Medisch Centrum
- Albert Schweitzer ZiekenhuisRecruiting
- Groene Hart Ziekenhuis
- Leids Universitair Medisch Centrum
- Alrijne Ziekenhuis
- Erasmus MC
- Maasstad ZiekenhuisRecruiting
- Universitair Medisch Centrum GroningenRecruiting
- Martini Ziekenhuis
- Universitair Medisch Centrum Utrecht
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Very short-course antibiotics
Standard course antibiotics
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
clinical cure rate by day 14 after ERCP without relapse by day 30
Clinical cure is defined as the absence of both fever (>38°C) and/or shaking chills, and initial presenting symptoms. Relapse is defined as the initiation of new antibiotic therapy for recurrent cholangitis, subsequent infection in the hepatic-pancreatic-biliary region, or any other subsequent infection possibly related to the initial episode of cholangitis.
Secondary Outcome Measures
All-cause 90-day mortality.
Mortality, which includes all causes.
Relapse of cholangitis within 90 days
Relapse is defined as the initiation of new antibiotic therapy for recurrent cholangitis, subsequent infection in the hepatic-pancreatic-biliary region, or any other subsequent infection possibly related to the initial episode of cholangitis.
Rate of any other subsequent infection requiring antibiotic therapy within 90 days.
Subsequent infections excluding recurrent cholangitis.
Rate of subsequent infections with MDR bacteria or Clostridioides difficile within 90 days.
Subsequent infections, in particular due to resistant bacteria.
Rate of other adverse drug events within 14 days
Includes: rash, diarrhoea (defined as ≥3 x loose stools per day), liver function abnormalities (defined as ≥5 x upper limit of normal (ULN) elevation in alanine aminotransferase (ALT) or ≥2 x ULN elevation in alkaline phosphatase (ALP) or ≥3 x ULN elevation in ALT and simultaneous elevation of total bilirubin concentration exceeding 2 x ULN (according to European association for the Study of the Liver Clinical Practice Guidelines: Drug-induced liver injury) AND without evidence of persistent obstruction on imaging OR elevation of liver enzymes after initial decrease. Lastly, other adverse drug events includes acute kidney injury, defined as increase in serum creatinine by ≥26.5 micromol/L within 48 hours or increase in serum creatinine to ≥1.5 times baseline (according to Kidney Disease: Improving Global Outcomes guidelines).
Length of intensive care and hospital stay for the initial episode of cholangitis.
Length of IC and hospital stay defined in days.
Quality of life and health utility.
This will be evaluated using the RAND-36 and EQ-5D-5L at day 7, day 30 and day 90.
Scale title (RAND-36): Research and Devevelopment-36 Minimum raw score: 45 Maximum raw score : 198 Higher scores mean a better outcome.
Scale title (EQ-5D-5L): European Quality of Life-5 Dimensions-5 Levels score Minimum score: 11111 Maximum score: 55555 Higher scores mean a worse outcome.
Societal costs and cost-effectiveness/-utility
The costs per cured patient without relapse and the costs per quality adjusted life year (QALY) Scale Title: Quality Adjusted Life Year. One quality-adjusted life year (QALY) is equal to 1 year of life in perfect health.QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale).
Minimum score: 0 Maximum score: 1 Higher scores mean a better outcome.
Full Information
NCT ID
NCT05750966
First Posted
February 3, 2023
Last Updated
July 19, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT05750966
Brief Title
Short-course Antibiotics vs Standard Course Antibiotics in Patients With Cholangitis
Acronym
COBRA
Official Title
Very Short-course Versus Standard Course Antibiotic Therapy in Patients With Acute ChOlangitis After Adequate Endoscopic BiliaRy drAinage
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2023 (Actual)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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?
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangitis
Keywords
antibiotics, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is designed as an open-label multicenter non-inferiority RCT. Patients will be randomly assigned to the intervention group (one day of ABT after ERCP) or the comparator group (4 to 7 days of ABT after ERCP).
Masking
None (Open Label)
Masking Description
Patients and investigators will know in which group they are assigned.
Allocation
Randomized
Enrollment
440 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Very short-course antibiotics
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard course antibiotics
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
cefrtriaxone, gentamicin, cefuroxim, ciprofloxin or other antibiotics according to local guideline (24 hours)
Other Intervention Name(s)
ceftriaxone, gentamicin, cefuroxim, ciprofloxacin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
cefrtriaxone, gentamicin, cefuroxim, ciprofloxin or other antibiotics according to local guideline (4 to 7 days)
Other Intervention Name(s)
ceftriaxone, gentamicin, cefuroxim, ciprofloxacin
Intervention Description
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.
Primary Outcome Measure Information:
Title
clinical cure rate by day 14 after ERCP without relapse by day 30
Description
Clinical cure is defined as the absence of both fever (>38°C) and/or shaking chills, and initial presenting symptoms. Relapse is defined as the initiation of new antibiotic therapy for recurrent cholangitis, subsequent infection in the hepatic-pancreatic-biliary region, or any other subsequent infection possibly related to the initial episode of cholangitis.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
All-cause 90-day mortality.
Description
Mortality, which includes all causes.
Time Frame
90 days
Title
Relapse of cholangitis within 90 days
Description
Relapse is defined as the initiation of new antibiotic therapy for recurrent cholangitis, subsequent infection in the hepatic-pancreatic-biliary region, or any other subsequent infection possibly related to the initial episode of cholangitis.
Time Frame
90 days
Title
Rate of any other subsequent infection requiring antibiotic therapy within 90 days.
Description
Subsequent infections excluding recurrent cholangitis.
Time Frame
90 days
Title
Rate of subsequent infections with MDR bacteria or Clostridioides difficile within 90 days.
Description
Subsequent infections, in particular due to resistant bacteria.
Time Frame
90 days
Title
Rate of other adverse drug events within 14 days
Description
Includes: rash, diarrhoea (defined as ≥3 x loose stools per day), liver function abnormalities (defined as ≥5 x upper limit of normal (ULN) elevation in alanine aminotransferase (ALT) or ≥2 x ULN elevation in alkaline phosphatase (ALP) or ≥3 x ULN elevation in ALT and simultaneous elevation of total bilirubin concentration exceeding 2 x ULN (according to European association for the Study of the Liver Clinical Practice Guidelines: Drug-induced liver injury) AND without evidence of persistent obstruction on imaging OR elevation of liver enzymes after initial decrease. Lastly, other adverse drug events includes acute kidney injury, defined as increase in serum creatinine by ≥26.5 micromol/L within 48 hours or increase in serum creatinine to ≥1.5 times baseline (according to Kidney Disease: Improving Global Outcomes guidelines).
Time Frame
14 days
Title
Length of intensive care and hospital stay for the initial episode of cholangitis.
Description
Length of IC and hospital stay defined in days.
Time Frame
30 days
Title
Quality of life and health utility.
Description
This will be evaluated using the RAND-36 and EQ-5D-5L at day 7, day 30 and day 90.
Scale title (RAND-36): Research and Devevelopment-36 Minimum raw score: 45 Maximum raw score : 198 Higher scores mean a better outcome.
Scale title (EQ-5D-5L): European Quality of Life-5 Dimensions-5 Levels score Minimum score: 11111 Maximum score: 55555 Higher scores mean a worse outcome.
Time Frame
90 days
Title
Societal costs and cost-effectiveness/-utility
Description
The costs per cured patient without relapse and the costs per quality adjusted life year (QALY) Scale Title: Quality Adjusted Life Year. One quality-adjusted life year (QALY) is equal to 1 year of life in perfect health.QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale).
Minimum score: 0 Maximum score: 1 Higher scores mean a better outcome.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Jeroen Bosch Ziekenhuis
City
Den Bosch
State/Province
Brabant
ZIP/Postal Code
5223 GZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bob CH Scheffer, MD PhD
Phone
0735333051
Email
b.scheffer@jbz.nl
First Name & Middle Initial & Last Name & Degree
Bob CH Scheffer, MD PhD
Facility Name
Catharina Ziekenhuis
City
Eindhoven
State/Province
Brabant
ZIP/Postal Code
5623 EJ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lennard Gilissen, MD PhD
Phone
0402399750
Email
lennard.gilissen@catharinaziekenhuis.nl
First Name & Middle Initial & Last Name & Degree
Lennard Gilissen, MD PhD
Facility Name
Elisabeth Tweesteden Ziekenhuis
City
Tilburg
State/Province
Brabant
ZIP/Postal Code
5022 GC
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wouter L. Hazen, MD PhD
Phone
0132213076
Email
wl.hazen@etz.nl
First Name & Middle Initial & Last Name & Degree
Wouter L. Hazen, MD PhD
Facility Name
Flevoziekenhuis
City
Almere
State/Province
Flevoland
ZIP/Postal Code
1315 RA
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marius Munneke, MD PhD
Phone
0368688888
Email
mmunneke@flevoziekenhuis.nl
First Name & Middle Initial & Last Name & Degree
Marius Munneke, MD PhD
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
State/Province
Friesland
ZIP/Postal Code
8934 AD
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaas Linde, van der, MD PhD
Phone
0582866950
Email
k.v.d.linde@mcl.nl
First Name & Middle Initial & Last Name & Degree
Klaas Linde, van der, MD PhD
Facility Name
Rijnstate Ziekenhuis
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6815 AD
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Maarten Vrolijk, MD
Phone
0880056800
Email
JVrolijk@rijnstate.nl
First Name & Middle Initial & Last Name & Degree
Jan Maarten Vrolijk, MD
Facility Name
Radboud umc
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Foke Delft, van, MD
Phone
0243619190
Email
Foke.vanDelft@radboudumc.nl
First Name & Middle Initial & Last Name & Degree
Foke Delft, van, MD
Facility Name
Canisius Wilhelmina Ziekenhuis
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6532 SZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriaan Tan, MD PhD
Phone
0243658070
Email
a.tan@cwz.nl
First Name & Middle Initial & Last Name & Degree
Adriaan Tan, MD PhD
Facility Name
Maastricht UMC+
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan-Werner Poley, MD PhD
Phone
0433875100
Email
jan.werner.poley@mumc.nl
First Name & Middle Initial & Last Name & Degree
Jan-Werner Poley, MD PhD
Facility Name
Amsterdam UMC
City
Amsterdam
State/Province
Noord Holland
ZIP/Postal Code
1081 HZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rogier P. Voermans, MD PhD
Phone
0650091301
Email
r.p.voermans@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Rogier P. Voermans, MD PhD
Facility Name
Amstelland Ziekenhuis
City
Amstelveen
State/Province
Noord-Holland
ZIP/Postal Code
1186 AM
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karam Boparai, MD PhD
Phone
0207557023
Email
k.boparai@zha.nl
First Name & Middle Initial & Last Name & Degree
Karam Boparai, MD PhD
Facility Name
OLVG
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1091 AC
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sjoerd D. Kuiken, MD PhD
Phone
0205108777
Email
s.kuiken@olvg.nl
First Name & Middle Initial & Last Name & Degree
Sjoerd D. Kuiken, MD PhD
Facility Name
Spaarne Gasthuis
City
Hoofddorp
State/Province
Noord-Holland
ZIP/Postal Code
2134 TM
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellert J. Soest, van, MD PhD
Phone
0232240075
Email
e.van.soest@spaarnegasthuis.nl
First Name & Middle Initial & Last Name & Degree
Ellert J. Soest, van, MD PhD
Facility Name
Dijklander Ziekenhuis
City
Hoorn
State/Province
Noord-Holland
ZIP/Postal Code
1624 AR
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pim W. Weijenborg, MD PhD
Phone
0229257823
Email
p.w.weijenborg@dijklander.nl
First Name & Middle Initial & Last Name & Degree
Pim W. Weijenborg, MD PhD
Facility Name
Zaans Medisch Centrum
City
Zaandam
State/Province
Noord-Holland
ZIP/Postal Code
1502 DV
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk Schölvinck, MD
Phone
0756501230
Email
Scholvinck.D@zaansmc.nl
First Name & Middle Initial & Last Name & Degree
Dirk Schölvinck, MD
Facility Name
Deventer Ziekenhuis
City
Deventer
State/Province
Overijssel
ZIP/Postal Code
7416 SE
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Borg, ten, MD PhD
Phone
0570535105
Email
frank2pad@icloud.com
First Name & Middle Initial & Last Name & Degree
Frank Borg, ten, MD PhD
Facility Name
Medisch Spectrum Twente
City
Enschede
State/Province
Overijssel
ZIP/Postal Code
7512 KZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niels Venneman, MD PhD
Phone
0534872410
Email
N.Venneman@mst.nl
First Name & Middle Initial & Last Name & Degree
Niels Venneman, MD PhD
Facility Name
Isala
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8025 AB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander C. Poen, MD PhD
Phone
0886246223
Email
a.c.poen@isala.nl
First Name & Middle Initial & Last Name & Degree
Alexander C. Poen, MD PhD
Facility Name
Meander MC
City
Amersfoort
State/Province
Utrecht
ZIP/Postal Code
3813 TZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Menno A. Brink, MD PhD
Phone
0338506070
Email
MA.Brink@meandermc.nl
First Name & Middle Initial & Last Name & Degree
Menno A. Brink, MD Phd
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435 CM
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert C. Verdonk, MD PhD
Phone
0883205600
Email
r.verdonk@antoniusziekenhuis.nl
First Name & Middle Initial & Last Name & Degree
Robert C. Verdonk, MD PhD
Facility Name
Reinier de Graaf Gasthuis
City
Delft
State/Province
Zuid-Holland
ZIP/Postal Code
2625 AD
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rutger Quispel, MD PhD
Phone
0152603200
Email
R.Quispel@rdgg.nl
First Name & Middle Initial & Last Name & Degree
Rutger Quispel, MD PhD
Facility Name
Haaglanden Medisch Centrum
City
Den Haag
State/Province
Zuid-Holland
ZIP/Postal Code
2512 VA
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars E. Perk, MD
Phone
0889794307
Email
l.perk@haaglandenmc.nl
First Name & Middle Initial & Last Name & Degree
Lars E. Perk, MD
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
State/Province
Zuid-Holland
ZIP/Postal Code
3318 AT
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wim Vrie, van de, MD PhD
Phone
0786541111
Email
w.vandevrie@asz.nl
First Name & Middle Initial & Last Name & Degree
Wim Vrie, van de, MD PhD
Facility Name
Groene Hart Ziekenhuis
City
Gouda
State/Province
Zuid-Holland
ZIP/Postal Code
2803 HH
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bart Opsteeg, MD
Phone
0182505050
Email
Bart.Opsteeg@ghz.nl
First Name & Middle Initial & Last Name & Degree
Bart Opsteeg, MD
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akin Inderson, MD
Phone
0715263575
Email
a.inderson@lumc.nl
First Name & Middle Initial & Last Name & Degree
Akin Inderson, MD
Facility Name
Alrijne Ziekenhuis
City
Leiderdorp
State/Province
Zuid-Holland
ZIP/Postal Code
2353 GA
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wouter Hollander, den, MD
Phone
0715828012
Email
wjdenhollander@alrijne.nl
First Name & Middle Initial & Last Name & Degree
Wouter Hollander, den, MD PhD
Facility Name
Erasmus MC
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pieter Jan Jonge, de, MD PhD
Phone
0107040572
Email
p.dejonge@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Pieter Jan Jonge, de, MD PhD
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3079 DZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammed Hadithi, MD PhD
Phone
0102911777
Email
HadithiM@maasstadziekenhuis.nl
First Name & Middle Initial & Last Name & Degree
Muhammed Hadithi, MD PhD
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frans Heide, van der, MD PhD
Phone
0503619259
Email
f.van.der.heide@umcg.nl
First Name & Middle Initial & Last Name & Degree
Frans Heide, van der, MD PhD
Facility Name
Martini Ziekenhuis
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Willem J. Thijs, MD
Phone
0505245940
Email
ThijsW@MZH.nl
First Name & Middle Initial & Last Name & Degree
Willem J. Thijs, MD
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Auke Bogte, MD
Phone
0887556276
Email
A.Bogte@umcutrecht.nl
First Name & Middle Initial & Last Name & Degree
Auke Bogte, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28941329
Citation
Miura F, Okamoto K, Takada T, Strasberg SM, Asbun HJ, Pitt HA, Gomi H, Solomkin JS, Schlossberg D, Han HS, Kim MH, Hwang TL, Chen MF, Huang WS, Kiriyama S, Itoi T, Garden OJ, Liau KH, Horiguchi A, Liu KH, Su CH, Gouma DJ, Belli G, Dervenis C, Jagannath P, Chan ACW, Lau WY, Endo I, Suzuki K, Yoon YS, de Santibanes E, Gimenez ME, Jonas E, Singh H, Honda G, Asai K, Mori Y, Wada K, Higuchi R, Watanabe M, Rikiyama T, Sata N, Kano N, Umezawa A, Mukai S, Tokumura H, Hata J, Kozaka K, Iwashita Y, Hibi T, Yokoe M, Kimura T, Kitano S, Inomata M, Hirata K, Sumiyama Y, Inui K, Yamamoto M. Tokyo Guidelines 2018: initial management of acute biliary infection and flowchart for acute cholangitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):31-40. doi: 10.1002/jhbp.509. Epub 2018 Jan 8.
Results Reference
background
PubMed Identifier
35953772
Citation
Sieswerda E, Bax HI, Hoogerwerf JJ, de Boer MGJ, Boermeester M, Bonten MJM, Dekker D, van Wijk RG, Juffermans NP, Kuindersma M, van der Linden PD, Melles DC, Pickkers P, Schouten JA, Rebel JR, van Zanten ARH, Prins JM, Wiersinga WJ. The 2021 Dutch Working Party on Antibiotic Policy (SWAB) guidelines for empirical antibacterial therapy of sepsis in adults. BMC Infect Dis. 2022 Aug 11;22(1):687. doi: 10.1186/s12879-022-07653-3.
Results Reference
background
PubMed Identifier
33462749
Citation
Haal S, Wielenga MCB, Fockens P, Leseman CA, Ponsioen CY, van Soest EJ, van Wanrooij RLJ, Sieswerda E, Voermans RP. Antibiotic Therapy of 3 Days May Be Sufficient After Biliary Drainage for Acute Cholangitis: A Systematic Review. Dig Dis Sci. 2021 Dec;66(12):4128-4139. doi: 10.1007/s10620-020-06820-3. Epub 2021 Jan 19.
Results Reference
background
Learn more about this trial
Short-course Antibiotics vs Standard Course Antibiotics in Patients With Cholangitis
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