Very short-course versus standard course antibiotic therapy in patients with acute ChOlangitis after adequate endoscopic BiliaRy drAinage (COBRA trial).
- Conditions
- bile duct infectioncholangitis1000460610004018
- Registration Number
- NL-OMON56128
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 440
- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>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.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are all-cause mortality, relapse of cholangitis, any other<br /><br>subsequent infection requiring antibiotic therapy, subsequent infections with<br /><br>multidrug resistant (MDR) bacteria or Clostridioides difficile, other adverse<br /><br>drug events, length of intensive care and hospital stay for the initial episode<br /><br>of cholangitis, quality of life and health utility, and societal costs.</p><br>