Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

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

Intervention / Treatment
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* Drug: Sulperazon
* Drug: Teicoplanin
* Drug: Meropenem Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 3 months to 2 years old, gender is not limited. Patients with cholangitis post-kasai Portoenterostomy. No other treatment before entering the group. The patient must sign an informed consent form and can actively cooperate with the treatment and follow-up. Exclusion Criteria: Patients with other infectious lesions. Patients with other severe deformity. Patients with end-stage liver failure. Patientsn with liver transplantation. Patients with mental symptoms or other disease.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: moderate cholangitis<br>Meropenem injection, iv. drip,20mg/Kg，Q12h; Tinidazole injection, iv. drip,20mg/Kg,Qd. | Drug: Sulperazon<br>* moderate cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.<br>* Other names: Tinidazole injection;|
| Experimental: severe cholangitis<br>Meropenem injection, iv. drip,20mg/Kg，Q8h; Teicoplanin injection, iv. drip,10mg/Kg,Qd; Tinidazole injection, iv. drip,20mg/Kg,Qd. | Drug: Teicoplanin<br>* severe cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.<br>* Other names: Tinidazole injection;|
| Active Comparator: control group<br>Sulperazon, iv.,drip,100mg/Kg,Bid; Tinidazole injection, iv. drip,20mg/Kg,Qd | Drug: Meropenem Injection<br>* cholangitis in control group were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.<br>* Other names: Tinidazole injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | To collect recurrent episode of cholangitis and recurrent rate of each group. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholangitis, biliary atresia, kasai Portoenterostomy, antibiotics, treatment