The primary objective is to investigate if a very short-course of antibiotics for cholangitis after adequate drainage is non-inferior with respect to clinical cure in comparison with a standard course of antibiotics.
ID
Source
Brief title
Condition
- Bile duct disorders
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is clinical cure 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.
Secondary outcome
Secondary endpoints are all-cause mortality, relapse of cholangitis, any other
subsequent infection requiring antibiotic therapy, subsequent infections with
multidrug resistant (MDR) bacteria or Clostridioides difficile, other adverse
drug events, length of intensive care and hospital stay for the initial episode
of cholangitis, quality of life and health utility, and societal costs.
Background summary
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.
Study objective
The primary objective is to investigate if a very short-course of antibiotics
for cholangitis after adequate drainage is non-inferior with respect to
clinical cure in comparison with a standard course of antibiotics.
Study design
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).
Intervention
Patients will be randomized to receive one day or 4-7 days of ABT after ERCP.
Study burden and risks
The risks of shortened ABT consist of insufficient treatment of cholangitis
potentially complicated by bacteraemia and recurrent infection. Although it is
assumed recurrent infections are often due to inadequate biliary drainage and
therefore may not be preventable with longer ABT. All patients will be
consented for the study and asked to contact their physician in case of fever
and/or shaking chills after hospital discharge.
The presumed benefits of a very short-course of ABT are a reduction in the
length of hospital stay, a decrease in antibiotic consumption and subsequent
antibiotic-related toxicity, and reduced development of antimicrobial
resistance in gram-negative bacteria.
The burden for patients participating in this trial is small. Patients will be
contacted by telephone at day 14, 30 and 90 after the ERCP to evaluate clinical
cure and adverse events which is part of daily clinical practice. In addition
they will be asked to answer questionnaires to assess quality of life, health
utility and cost effectiveness at three points in time.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
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 bile with or without a biliary stent(s))
- Age >= 18 years
- Written informed consent
Exclusion criteria
- Other etiologies of acute cholangitis (e.g. primary sclerosing cholangitis,
(sub)hilar and/or intrahepatic strictures or hilar stents)
- A recurrent cholangitis (within 3 months)
- Concomitant pancreatitis, cholecystitis or liver abscess
- Another additional infectious diagnosis
- Use of maintenance antimicrobial therapy
- Use of immunosuppressants
- Neutropenia
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2022-002624-12-NL |
| CCMO | NL80410.029.22 |