Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03422042|
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Cholangitis Common Bile Duct Calculi||Other: Short duration of antibiotic Other: Standard treatment of antibiotic||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||February 13, 2013|
|Estimated Primary Completion Date :||February 20, 2019|
|Estimated Study Completion Date :||November 30, 2021|
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
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
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
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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422042
|Contact: Nisa Netinatsunton, MD.||6674451965 ext firstname.lastname@example.org|
|Contact: Bancha Ovartlarnporn, MD.||6674451965 ext email@example.com|
|NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University||Recruiting|
|Hatyai, Songkla, Thailand, 90110|
|Contact: Dr. Nisa Netinatsunton, MD 8874451965 ext 9 firstname.lastname@example.org|
|Contact: Dr.Bancha Ovartalaporn, MD 8874451965 ext 9 email@example.com|
|Principal Investigator: Nisa Netinatsunton, MD|
|Principal Investigator:||Nisa Netinatsunton, MD.||NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand, 90110.|