Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, 56000, Malaysia
Location status: Recruiting
Location contact
Azlanudin Azman
CONTACT
Azlanudin Azman
PRINCIPAL_INVESTIGATOR
Ian Chik
SUB_INVESTIGATOR
Tiew Toot Chaw
CONTACT
NCT Number: NCT07407491
Does intraductal administration of antibiotics during endoscopic retrograde cholangiopancreatography (ERCP), in addition to standard systemic antibiotic therapy, improve clinical outcomes in patients with acute cholangitis compared with standard systemic antibiotic therapy alone?
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Cheras, Kuala Lumpur, 56000, Malaysia
Location status: Recruiting
Azlanudin Azman
CONTACT
Azlanudin Azman
PRINCIPAL_INVESTIGATOR
Ian Chik
SUB_INVESTIGATOR
Tiew Toot Chaw
CONTACT
Acute cholangitis is a serious infection of the biliary system caused by biliary obstruction and infected bile, which may rapidly progress to sepsis if not promptly treated. Standard management includes systemic antibiotics and urgent biliary drainage, most commonly by endoscopic retrograde cholangiopancreatography (ERCP). However, biliary obstruction may impair biliary excretion of systemically administered antibiotics, resulting in subtherapeutic antibiotic concentrations within infected bile. Intraductal administration of antibiotics during ERCP may achieve higher local antimicrobial concentrations at the site of infection. This study evaluates the efficacy and safety of intraductal antibiotic administration during ERCP as an adjunct to standard systemic antibiotic therapy in patients with acute cholangitis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administration described in arm/group description
Administration described in arm/group description
Time frame: Evaluated at specific timepoints at admission, on the day of ERCP (pre-procedure), and daily from Day 1 to Day 3 following ERCP.
Time frame: From hospital admission through hospital discharge during the index hospitalization (up to approximately 30 days).
Total duration of hospitalization, calculated as the number of days from the date of hospital admission to the date of hospital discharge following the index ERCP procedure.
Time frame: From initiation of intravenous antibiotic therapy after hospital admission through discontinuation of intravenous antibiotics during the index hospitalization (up to approximately 30 days).
Criteria for intravenous to per oral switch antibiotic:
Time frame: Evaluated at specific timepoints during the procedure until day 3 following ERCP.
Peri-procedural complications assessed by post-ERCP monitoring, including pancreatitis, procedure-related bleeding, cardiopulmonary complications, gastrointestinal perforation, and sedation-related adverse events, recorded until day 3 following ERCP.
Contact information is provided by the study sponsor or research team.
Azlanudin Azman
CONTACT
Tiew Toot Chaw
CONTACT
National University of Malaysia
Other
Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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