Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

Phase 4

Completed

• Conditions: Cholangitis, Secondary Biliary; Treatment Compliance; Antibodies Drug Specific
• Interventions: Drug: Sulperazon; Drug: Meropenem Injection; Drug: Teicoplanin

• Registration Number: NCT04370145
• Lead Sponsor: Tongji Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-04-30
• Study Start: 2021-05-01
• Primary Completion: 2021-10-01
• Status Verified: 2022-04
• Study Completion: 2022-04-01
• Last Update Submitted: 2022-04-03
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
moderate cholangitis	Sulperazon	Meropenem injection, iv. drip,20mg/Kg，Q12h; Tinidazole injection, iv. drip,20mg/Kg,Qd.
control group	Meropenem Injection	Sulperazon, iv.,drip,100mg/Kg,Bid; Tinidazole injection, iv. drip,20mg/Kg,Qd
severe cholangitis	Teicoplanin	Meropenem injection, iv. drip,20mg/Kg，Q8h; Teicoplanin injection, iv. drip,10mg/Kg,Qd; Tinidazole injection, iv. drip,20mg/Kg,Qd.

Primary Outcome Measures

Name	Time	Method
Recovery rate	7 days	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.

Secondary Outcome Measures

Name	Time	Method
Recurrence rate	1 year	To collect recurrent episode of cholangitis and recurrent rate of each group.

Trial Locations

Locations (2)

Tongji hospital affiliated to tongji medical college of huazhong university of science and technology; 🇨🇳 Wuhan, Hubei, China

TongjiHospital; 🇨🇳 Wuhan, Hubei, China