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Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis

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ClinicalTrials.gov Identifier: NCT03422042
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Nisa Netinatsunton, Prince of Songkla University

Tracking Information
First Submitted Date  ICMJE January 30, 2018
First Posted Date  ICMJE February 5, 2018
Last Update Posted Date February 7, 2018
Actual Study Start Date  ICMJE February 13, 2013
Estimated Primary Completion Date February 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2018)
The recurrence rate of cholangitis [ Time Frame: 8 weeks ]
The number of patients who has recurrence of fever after complete treatment without other sources identified
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03422042 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2018)
  • The rate of adequacy of drainage [ Time Frame: 24 hours ]
    The number of patient with cholangiography at the end of the procedure showed no fill defect in the bile duct.
  • Complication rate [ Time Frame: 4 weeks ]
    The number of patients who developed complications related procedure included pancreatitis, bleeding, perforation, cholangitis as defined and graded according to the consensus guideline and sedation related complications.
  • Mortality rate [ Time Frame: 4 weeks ]
    The number of patient with death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis
Official Title  ICMJE An Open-labeled, Randomized Controlled Trial Comparing Between Short Duration And Standard Fourteen Days Antibiotic Treatments In Patients With Acute Common Bile Duct Stone Cholangitis After Successful Endoscopic Biliary Drainage
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Cholangitis
  • Common Bile Duct Calculi
Intervention  ICMJE
  • Other: 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.
    Other Name: G1
  • 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.
    Other Name: G2
Study Arms  ICMJE
  • Active Comparator: 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
    Intervention: Other: Short duration of antibiotic
  • Active Comparator: 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
    Intervention: Other: Standard treatment of antibiotic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2018)
92
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2021
Estimated Primary Completion Date February 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nisa Netinatsunton, MD. 6674451965 ext 9 nisasan@yahoo.com
Contact: Bancha Ovartlarnporn, MD. 6674451965 ext 9 obancha@live.com
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03422042
Other Study ID Numbers  ICMJE REC 56-124-21-1-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The individual data of patients participating in the study are not available for public sharing since the investigators did not obtain the consent to share the data of patient
Responsible Party Nisa Netinatsunton, Prince of Songkla University
Study Sponsor  ICMJE Prince of Songkla University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nisa Netinatsunton, MD. NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand, 90110.
PRS Account Prince of Songkla University
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP