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