Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis

NCT03422042 | Completed

• 1 other identifier: REC 56-124-21-1-2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cholangitis; Common Bile Duct Calculi

Outcome Measures

Primary Outcomes (1)

• The recurrence rate of cholangitis

  The number of patients who has recurrence of fever after complete treatment without other sources identified

  8 weeks

Secondary Outcomes (3)

• The rate of adequacy of drainage

  24 hours

• Complication rate

  4 weeks

• Mortality rate

  4 weeks

Study Arms (2)

Short duration of antibiotic

ACTIVE COMPARATOR

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

Other: Short duration of antibiotic

Standard treatment of antibiotic

ACTIVE COMPARATOR

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

Other: Standard treatment of antibiotic

Interventions

Short duration of antibiotic OTHER

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

Also known as: G1

Short duration of antibiotic

Standard treatment of antibiotic OTHER

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

Also known as: G2

Standard treatment of antibiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Nisa Netinatsunton, MD.

  NKC Institute of Gastroenterology and Hepatology.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 5, 2018
• Study Start: August 13, 2017
• Primary Completion: February 20, 2019
• Study Completion: August 30, 2019
• Last Updated: March 4, 2020

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)