Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

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.

Study Overview

• Status: Completed
• Conditions: Treatment Compliance; Cholangitis, Secondary Biliary; Antibodies Drug Specific
• Intervention / Treatment: Drug: Sulperazon; Drug: Teicoplanin; Drug: Meropenem Injection

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430030
      • TongjiHospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Collaborators: Shanghai Children's Hospital
• Investigators: Principal Investigator: Feng Jiexiong, Postdoctoral, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 3, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: treatment; antibiotics; Cholangitis; biliary atresia; kasai Portoenterostomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Cholangitis; Liver Cirrhosis, Biliary; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Alkylating Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents, Urinary; Renal Agents; Antitrichomonal Agents; Meropenem; Tinidazole; Sulperazone; Teicoplanin
• Other Study ID Numbers: JXFeng

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No