Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

Tongji Hospital

Status and phase: Completed; Phase 4

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

Treatments: Drug: Meropenem Injection; Drug: Sulperazon; Drug: Teicoplanin

Study type: Interventional

Funder types: Other

Identifiers

NCT04370145

JXFeng

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 3 months to 2 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 3 patient groups

moderate cholangitis

Experimental group

Description:

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

Treatment:

Drug: Sulperazon

severe cholangitis

Experimental group

Description:

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

Treatment:

Drug: Teicoplanin

control group

Active Comparator group

Description:

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

Treatment:

Drug: Meropenem Injection