Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in China / NCT05925309
Recruiting Not applicable

Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy

NCT05925309 · tracked via the Priya Life Science China tracker
Sponsor
Children's Hospital of Fudan University
Phase
Not applicable
Started
2023-07-01
Last updated
2026-05-15

Condition(s) studied

Biliary AtresiaCholangitisAnti-Bacterial Agents

Investigational drug(s) / intervention(s)

Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenemAll Ursodeoxycholic Acid trials (11) →All Methylprednisolone trials (75) →All Imipenem trials (4) →All Meropenem trials (14) →Prophylactic oral antibiotics: compound sulfamethoxazole tablet (SMZ/TMP) + cefaclor →

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
14 Days
Max age
90 Days
Healthy volunteers
No
Inclusion Criteria: * Patients whose age of operation is 14-90 d. Sex and race are not restricted; * Patients who are born with gestational age older than 36 weeks; * Patients whose body weight before operation \> 2 kg; * Patients diagnosed of type-III BA and underwent KP in Children's Hospital of Fudan University; * The type-III BA diagnosis is based on cholangiography or operation; * Patients whose histological features of liver biopsies are reported. HE staining and Masson staining are required, and edema, inflammation, fibrosis, and hyperplasia of intrahepatic bile duct should be reported; * Patients who are not allergic to postoperative medications; * Patients who haven't accepted other antibiotic or probiotic therapy. Exclusion Criteria: * Patients with cholestasis of non-BA disease; * Patients who have undergone KP at other institutions; * Patients whose pathohistological diagnosis is in doubt; * Patients who undergo liver transplantation immediately after KP; * Patients with other liver diseases or severe complications (e.g., severe pulmonary hypertension, renal failure, intracranial hemorrhage, etc.) requiring surgical intervention or other medical therapy; * Patients with severe cardiac, renal, or central nerve system malformations (e.g., tetralogy of Fallot, transposition of the great arteries, cerebral dysplasia, etc.) and have poor prognosis; * Patients judged by the researchers that they can not comply with the study requirements.

Primary outcome measure(s)

  • The occurrence of cholangitis (confirmed or suspected) within 6 months after KP — 6 months after KP
    Definition of cholangitis: A. Clinical elements 1. Fever and/or shivering; 2. Stool color change; 3. New/increasing jaundice; 4. Abdominal discomfort: vomiting, poor, feeding, irritability. B. Laboratory and imaging elements 1. Inflammatory response (WBC and/or CRP and/or PCT); 2. Increased/increasing transaminases; 3. Increased/increasing GGT and/or bilirubin; 4. Bile lakes. Suspected cholangitis: one item in A + one item in B. Confirmed cholangitis: two items in A + two items in B or "suspected cholangitis" + positive blood culture. The diagnosis of cholangitis requires the exclusion of definite infections of other systems.

Trial sites (1)

FacilityCityRegionStatus
Children's Hospital of Fudan University Shanghai Shanghai Municipality Recruiting

More Children's Hospital of Fudan University trials in China

Clinical Implementation of the Group Standard for Enteral Feeding Care in Critically Ill Children Starting soon
PK/PD of Ceftazidime Avitbatan Sodium in Children With Severe Infection Recruiting
YTS109 in Pediatric Relapsed/Refractory Autoimmune Diseases Starting soon
Development of an Early Warning Model for Intensive Care Unit-Acquired Weakness in Mechanically Ventilated Children Enrolling by invitation
Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder Recruiting

Other trials for the same condition

An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia Active, not recruiting
Prospective Cohort Study on Antibiotic Course and Efficacy After Two-stage Revision in PJI. Recruiting
Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma Starting soon
Nutritional Intervention for Biliary Atresia Recruiting
Preoperative Serum FGF19 in the Prognosis of Biliary Atresia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05925309 on ClinicalTrials.gov ↗ ← All trials in China