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

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Feb 28, 2023

Keywords

ClinConnect Summary

This clinical trial is looking to find out if taking antibiotics for just one day is as effective as the standard treatment, which lasts for 4 to 7 days, for patients with cholangitis. Cholangitis is an infection in the bile duct, often caused by blockages like stones. The study aims to see if a shorter course of antibiotics can still help patients recover without increasing the risk of relapse, death, or adverse effects from the medication. It also seeks to determine if this shorter treatment can lead to shorter hospital stays and better quality of life for patients.

To participate in this trial, you need to be at least 18 years old and have been diagnosed with acute cholangitis due to specific causes, such as bile duct stones. You should have already had a procedure to clear the blockage and be stable, meaning you don’t have a fever and your health is improving. Participants will receive either the one-day or standard course of antibiotics and will be monitored for their recovery. This study is currently recruiting, so it’s a great opportunity for eligible patients to help advance treatment options for cholangitis.

Gender

ALL

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 \<38.5°C) or a decrease of body temperature of at least 1°C has occurred within 24 hours after ERCP
• • Age ≥ 18 years
• • Written informed consent (IC)
• Exclusion Criteria:
• • Other aetiologies 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, according to International Association of Pancreatology/American Pancreatic Association guidelines.\[18\] Acute pancreatitis is diagnosed in case of fulfilment of 2 out of 3 of the following criteria:
• • Upper abdominal pain
• • Serum amylase or lipase \>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