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Completed NCT05750966

Short-course Antibiotics vs Standard Course Antibiotics in Patients With Cholangitis

Conditions: Cholangitis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 410
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Location: Flevoziekenhuis Almere Stad Flevoland

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?

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 \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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05750966). StuddyBuddy aggregates publicly available trial information.