Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis

NCT ID: NCT03422042

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-13
• Study Completion Date: 2019-08-30

Brief Summary

Common bile duct stone cholangitis is a potentially fatal condition, characterized by an obstruction and bacterial infection of biliary system. The principles of management are appropriate biliary drainage and systemic antibiotics. There has been limited data about appropriate time of antibiotics in patient with successful endoscopic drainage.

Detailed Description

The aim is comparing the efficacy and safety between short duration and standard fourteen days antibiotic treatment in patients with acute common bile duct stone (CBDS) cholangitis after successful endoscopic biliary drainage as regards recurrence rate of acute cholangitis, complete stone clearance rate, morbidity and mortality associated acute cholangitis, and complications related ERCP procedure.

The study will be divided patients with acute CBDS cholangitis with complete stone clearance into 2 groups, group (A) will be received intravenous antibiotic until the temperature is less than 37.8 c for 72 hours and group (B) will be received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.

Conditions

Acute Cholangitis; Common Bile Duct Calculi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Short duration of antibiotic

group A: will received intravenous antibiotic until the temperature is less than 37.8 c for 72 hours, then antibiotic is discontinued

Group Type: ACTIVE_COMPARATOR

Short duration of antibiotic

Intervention Type: OTHER

Patient will received intravenous antibiotic until the body temperature is less than 37.8 c fir 72, then antibiotic is discontinued.

Standard treatment of antibiotic

group B: will received intravenous antibiotic for 7 days, and followed by oral antibiotic for 7 days, regardless of body temperature

Group Type: ACTIVE_COMPARATOR

Standard treatment of antibiotic

Intervention Type: OTHER

Patient will received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.

Interventions

Short duration of antibiotic

Patient will received intravenous antibiotic until the body temperature is less than 37.8 c fir 72, then antibiotic is discontinued.

Intervention Type: OTHER

Standard treatment of antibiotic

Patient will received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.

Intervention Type: OTHER

Other Intervention Names

G1; G2

Eligibility Criteria

Inclusion Criteria

• age ≥ 18 years old
• diagnosis of acute mild to moderate severity of ascending common bile duct stone cholangitis
• endoscopic retrograde cholangiopancreatography (ERCP) with biliary drainage within 72 hours after admission

Exclusion Criteria

• pregnant woman
• the cause of obstruction other than common bile duct stone
• severe co-morbid diseases such as cardiovascular/pulmonary/kidney disease
• active concomitant infections of other organs
• history of allergy to cephalosporin group

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prince of Songkla University

OTHER

Sponsor Role: lead

Responsible Party

Nisa Netinatsunton

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nisa Netinatsunton, MD.

Role: PRINCIPAL_INVESTIGATOR

NKC Institute of Gastroenterology and Hepatology.

Locations

NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Countries

Thailand

Other Identifiers

REC 56-124-21-1-2

Identifier Type: -

Identifier Source: org_study_id