Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

NCT04370145 | Completed Phase 4

• 1 other identifier: JXFeng
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Cholangitis, Secondary Biliary; Treatment Compliance; Antibodies Drug Specific

Keywords

Cholangitis; biliary atresia; kasai Portoenterostomy; antibiotics; treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Recurrence rate

  1 year

Study Arms (3)

moderate cholangitis

EXPERIMENTAL

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

Drug: Sulperazon

severe cholangitis

EXPERIMENTAL

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

Drug: Teicoplanin

control group

ACTIVE COMPARATOR

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

Drug: Meropenem Injection

Interventions

Sulperazon DRUG

moderate cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.

Also known as: Tinidazole injection

moderate cholangitis

Teicoplanin DRUG

severe cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.

Also known as: Meropenem Injection, Tinidazole injection

severe cholangitis

Meropenem Injection DRUG

cholangitis in control group were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.

Also known as: Tinidazole injection

control group

Eligibility Criteria

• Age: 3 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead
• Shanghai Children's Hospital: collaborator

Study Sites (2)

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

Wuhan, Hubei, 430030, China

Location

TongjiHospital

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

• Wang P, Zhang HY, Yang J, Zhu T, Wu X, Yi B, Sun X, Wang B, Wang T, Tang W, Xie H, Tou J, Han Y, Liu X, Zhan J, Liu Y, Li Y, Lv Z, Lu L, Zhao B, Fu T, Wu D, Bai J, Li W, Yang H, Zhang G, Ren H, Feng J. Severity assessment to guide empiric antibiotic therapy for cholangitis in children after Kasai portoenterostomy: a multicenter prospective randomized control trial in China. Int J Surg. 2023 Dec 1;109(12):4009-4017. doi: 10.1097/JS9.0000000000000682.

  PMID: 37678274 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis, Biliary; Patient Compliance; Cholangitis; Biliary Atresia

Interventions

sulperazone; Tinidazole; Teicoplanin; Meropenem

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lipoglycopeptides; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Feng Jiexiong, Postdoctoral

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief in Department

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 30, 2020
• Study Start: May 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: April 1, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)