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NCT Number: NCT04370145

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.

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Key information

Conditions

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

Age range

3 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tongji hospital affiliated to tongji medical college of huazhong university of science and technology, Wuhan, Hubei, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sulperazon

Drug

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

Teicoplanin

Drug

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

Other names: Meropenem Injection, Tinidazole injection

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.

Other names: Tinidazole injection

Primary outcomes

  1. Recovery rate

    Time frame: 7 days

    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 outcomes

  1. Recurrence rate

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

  • Shanghai Children's Hospital

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 30, 2020
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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