search
Back to results

Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

Primary Purpose

Cholangitis, Secondary Biliary, Treatment Compliance, Antibodies Drug Specific

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sulperazon
Teicoplanin
Meropenem Injection
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangitis, Secondary Biliary focused on measuring Cholangitis, biliary atresia, kasai Portoenterostomy, antibiotics, treatment

Eligibility Criteria

3 Months - 2 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Tongji hospital affiliated to tongji medical college of huazhong university of science and technology
  • TongjiHospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

moderate cholangitis

severe cholangitis

control group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Recurrence rate
To collect recurrent episode of cholangitis and recurrent rate of each group.

Full Information

First Posted
April 23, 2020
Last Updated
April 3, 2022
Sponsor
Tongji Hospital
Collaborators
Shanghai Children's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04370145
Brief Title
Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy
Official Title
Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
Collaborators
Shanghai Children's Hospital

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangitis, Secondary Biliary, Treatment Compliance, Antibodies Drug Specific
Keywords
Cholangitis, biliary atresia, kasai Portoenterostomy, antibiotics, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
moderate cholangitis
Arm Type
Experimental
Arm Description
Meropenem injection, iv. drip,20mg/Kg，Q12h; Tinidazole injection, iv. drip,20mg/Kg,Qd.
Arm Title
severe cholangitis
Arm Type
Experimental
Arm Description
Meropenem injection, iv. drip,20mg/Kg，Q8h; Teicoplanin injection, iv. drip,10mg/Kg,Qd; Tinidazole injection, iv. drip,20mg/Kg,Qd.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Sulperazon, iv.,drip,100mg/Kg,Bid; Tinidazole injection, iv. drip,20mg/Kg,Qd
Intervention Type
Drug
Intervention Name(s)
Sulperazon
Other Intervention Name(s)
Tinidazole injection
Intervention Description
moderate cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.
Intervention Type
Drug
Intervention Name(s)
Teicoplanin
Other Intervention Name(s)
Meropenem Injection, Tinidazole injection
Intervention Description
severe cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.
Intervention Type
Drug
Intervention Name(s)
Meropenem Injection
Other Intervention Name(s)
Tinidazole injection
Intervention Description
cholangitis in control group were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.
Primary Outcome Measure Information:
Title
Recovery rate
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Recurrence rate
Description
To collect recurrent episode of cholangitis and recurrent rate of each group.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 3 months to 2 years old, gender is not limited. Patients with cholangitis post-kasai Portoenterostomy. No other treatment before entering the group. The patient must sign an informed consent form and can actively cooperate with the treatment and follow-up. Exclusion Criteria: Patients with other infectious lesions. Patients with other severe deformity. Patients with end-stage liver failure. Patientsn with liver transplantation. Patients with mental symptoms or other disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Jiexiong, Postdoctoral
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji hospital affiliated to tongji medical college of huazhong university of science and technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
TongjiHospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

We'll reach out to this number within 24 hrs