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RECRUITING
NCT05925309
NA

Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy

Sponsor: Children's Hospital of Fudan University

View on ClinicalTrials.gov

Summary

This study is non-inferiority trial design. This study aimed to investigate the effect of prophylactic oral antibiotics on preventing cholangitis in biliary atresia (BA) patients after Kasai portoenterostomy (KP) by comparing the cholangitis rate in BA patients who received prophylactic oral antibiotics and those who did not. The patients were followed up for 2 years after KP.

Official title: Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy in Biliary Atresia: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

14 Days - 90 Days

Study Type

INTERVENTIONAL

Enrollment

356

Start Date

2023-07-01

Completion Date

2027-07-31

Last Updated

2024-10-21

Healthy Volunteers

No

Interventions

DRUG

Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenem

Sulperazone 50mg/kg q8h is used intravenously from the first day to the 14th day after KP surgery. Ursodeoxycholic acid 20mg/kg/d p.o, starting from the 5th day after surgery for at least 2 years. Compound glycyrrhizin 20mg/d i.v, 1-4 days after operation, then switch to compound glycyrrhizin tablets 12.5mg b.i.d p.o until 6 months after KP. Methylprednisolone start at 4mg/kg/d i.v on the 8th day after operation, and decrease by 1mg/kg/d every three days. Starting at about the 15th day after operation, methylprednisolone 4mg/kg is given orally every other day, and the dose is gradually reduced at 10-12 weeks. Vitamin AD , D , E , K, are given orally from the 5th day after the KP for at least 2 months. Treatment of cholangitis: sulperazone 50mg/kg q8h i.v., and methylprednisolone could be used. If cholangitis is not controlled, imipenem or meropenem may be used.

DRUG

Prophylactic oral antibiotics: compound sulfamethoxazole tablet (SMZ/TMP) + cefaclor

Compound sulfamethoxazole tablet (SMZ/TMP) 25 mg/kg/d p.o. and cefaclor 12.5 mg/kg/d p.o. alternately every 2 weeks, from post-operation day 15 to month 6.

Locations (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China