Very short-course versus standard course antibiotic therapy in patients with acute ChOlangitis after adequate endoscopic BiliaRy drAinage (COBRA trial).

Very short-course versus standard course antibiotic therapy in patients with acute ChOlangitis after adequate endoscopic BiliaRy drAinage (COBRA trial). - COBRA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56128

Enrollment

416

Registered

2022-07-14

Start date

2023-03-14

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cholangitis

Interventions

Patients will be randomized to receive one day or 4-7 days of ABT after ERCP.

Eligibility

Age

18 Years to 99 Years

Inclusion 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 14 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 yearsWritten informed consent

Exclusion criteria

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)Patients with surgically altered anatomy (leading to biliary-enteric anastomosis) Concomitant pancreatitis, cholecystitis or liver abscessAnother additional infectious diagnosisAdmission on intensive care unit at time of randomizationUse of maintenance antimicrobial therapyUse of specific immunosuppressantsNeutropenia

Design outcomes

Primary

Measure	Time frame
The primary endpoint is clinical cure, defined as the patient being symptom-free by day 14 with no relapse or death occurring by day 30.	—

Secondary

Measure	Time frame
Secondary endpoints are all-cause 30-day and 90-day mortality, relapse of cholangitis within 90 days, time from ERCP to first relapse, time from last day of antibiotic therapy to first relapse, any other subsequent infection requiring antibiotic therapy within 90 days, subsequent infections with multidrug resistant (MDR) bacteria or Clostridioides difficile, length of initial antibiotic therapy course, number of days treated with antibiotic therapy within 30 days, initial hospital stay, total hospital stay within 30 and 90 days, length of intensive care stay during initial hospital admission, other adverse drug events, quality of life and health utility, and societal costs.	—

Measure

Time frame

Secondary endpoints are all-cause 30-day and 90-day mortality, relapse of cholangitis within 90 days, time from ERCP to first relapse, time from last day of antibiotic therapy to first relapse, any other subsequent infection requiring antibiotic therapy within 90 days, subsequent infections with multidrug resistant (MDR) bacteria or Clostridioides difficile, length of initial antibiotic therapy course, number of days treated with antibiotic therapy within 30 days, initial hospital stay, total hospital stay within 30 and 90 days, length of intensive care stay during initial hospital admission, other adverse drug events, quality of life and health utility, and societal costs.

—

Countries

Netherlands

Contacts

Public ContactR.P. Voermans

Amsterdam UMC

secretariaatmdl@amsterdamumc.nl(020) 444 3690

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 17, 2026