NCT04370145

Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 3 Months – 2 Years
• Healthy volunteers: Not accepted

Summary

Application of multi-center, prospective study on the severity of postoperative cholangitis biliary atresia classification, according to the degree of cholangitis targeted therapy, to improve the therapeutic effect of postoperative cholangitis biliary atresia, decrease the overuse of antibiotics related complications.

Detailed description

Cholangitis patients post-kasai Portoenterostomy were grouped by cholangitis severity score, according to the severity was divided into mild, moderate, severe cholangitis, all levels of cholangitis patients were divided into subgroups by age and post-kasai Portoenterostomy jaundice matching design of experiment, then they were randomly divided into control group and experimental group, and all the control group unified antibiotic treatment, the experimental group was graded antibiotic treatment according to the severity cholangitis, after three days treatment，evaluate each treatment effect, average hospitalization days, the average hospitalization expenses, antimicrobial drug use strength to evaluate the therapeutic effect of postoperative cholangitis biliary atresia.

Conditions

• Cholangitis, Secondary Biliary
• Treatment Compliance
• Antibodies Drug Specific

Interventions

Type	Name	Description
DRUG	Sulperazon	moderate cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.
DRUG	Teicoplanin	severe cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.
DRUG	Meropenem Injection	cholangitis in control group were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.

Timeline

• Start date: 2021-05-01
• Primary completion: 2021-10-01
• Completion: 2022-04-01
• First posted: 2020-04-30
• Last updated: 2022-04-11

Locations

2 sites across 1 country: China