Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-04-01

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.

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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.

Conditions

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Cholangitis, Secondary Biliary Treatment Compliance Antibodies Drug Specific

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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moderate cholangitis

Meropenem injection, iv. drip,20mg/Kg，Q12h; Tinidazole injection, iv. drip,20mg/Kg,Qd.

Group Type EXPERIMENTAL

Sulperazon

Intervention Type DRUG

moderate cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.

severe cholangitis

Meropenem injection, iv. drip,20mg/Kg，Q8h; Teicoplanin injection, iv. drip,10mg/Kg,Qd; Tinidazole injection, iv. drip,20mg/Kg,Qd.

Group Type EXPERIMENTAL

Teicoplanin

Intervention Type DRUG

severe cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.

control group

Sulperazon, iv.,drip,100mg/Kg,Bid; Tinidazole injection, iv. drip,20mg/Kg,Qd

Group Type ACTIVE_COMPARATOR

Meropenem Injection

Intervention Type DRUG

cholangitis in control group were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.

Interventions

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Sulperazon

moderate cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.

Intervention Type DRUG

Teicoplanin

severe cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Tinidazole injection Meropenem Injection Tinidazole injection Tinidazole injection

Eligibility Criteria

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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.

Minimum Eligible Age

3 Months

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No