Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

Treatment Compliance Clinical Trial

Official title:

Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04370145
• Other study ID #: JXFeng
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2022
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 2 Years

Eligibility

Inclusion Criteria:

1. Age 3 months to 2 years old, gender is not limited.

2. Patients with cholangitis post-kasai Portoenterostomy.

3. No other treatment before entering the group.

4. The patient must sign an informed consent form and can actively cooperate with the treatment and follow-up.

Exclusion Criteria:

1. Patients with other infectious lesions.

2. Patients with other severe deformity.

3. Patients with end-stage liver failure.

4. Patientsn with liver transplantation.

5. Patients with mental symptoms or other disease.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Tongji hospital affiliated to tongji medical college of huazhong university of science and technology	Wuhan	Hubei
China	TongjiHospital	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Tongji Hospital	Shanghai Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery rate	The cure indicator including:1.Temperature:T=37.5?; 2. Infection index:WBC<10x109/L, CRP<10mg/L. After 7days treatment, we calculate the cure number and recovery rate of each group to evaluate the efficiency.	7 days
Secondary	Recurrence rate	To collect recurrent episode of cholangitis and recurrent rate of each group.	1 year