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Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04370145
Recruitment Status : Not yet recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Collaborator:
Shanghai Children's Hospital
Information provided by (Responsible Party):
J.X. Feng, Tongji Hospital

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.

Condition or disease Intervention/treatment Phase
Cholangitis, Secondary Biliary Treatment Compliance Antibodies Drug Specific Drug: Sulperazon Drug: Teicoplanin Drug: Meropenem Injection Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
Drug Information available for: Meropenem

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 Name: 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:
  • Meropenem Injection
  • Tinidazole 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 Name: Tinidazole injection




Primary Outcome Measures :
  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 Outcome Measures :
  1. Recurrence rate [ Time Frame: 1 year ]
    To collect recurrent episode of cholangitis and recurrent rate of each group.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04370145


Contacts
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Contact: Feng Jiexiong, Postdoctoral 18607187276 ext 86- wangpeipeggy@126.com
Contact: Yang Jixin, Doctor 15927121656 ext 86- yangjixin0910@126.com

Locations
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China, Hubei
Tongji hospital affiliated to tongji medical college of huazhong university of science and technology
Wuhan, Hubei, China, 430030
Contact: Feng Jiexiong, Postdoctoral    18607187276 ext 86-    wangpeipeggy@126.com   
Contact: Yang Jixin, Doctor    15927121656 ext 86-    yangjixin0910@126.com   
TongjiHospital
Wuhan, Hubei, China, 430030
Contact: Feng Jiexiong, Postdoctoral    18607187276 ext 86-    wangpeipeggy@126.com   
Contact: Yang Jixin, Doctor    15927121656 ext 86-    yangjixin0910@126.com   
Sponsors and Collaborators
Tongji Hospital
Shanghai Children's Hospital
Investigators
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Principal Investigator: Feng Jiexiong, Postdoctoral Tongji Hospital
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Responsible Party: J.X. Feng, Chief in Department, Tongji Hospital
ClinicalTrials.gov Identifier: NCT04370145    
Other Study ID Numbers: JXFeng
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by J.X. Feng, Tongji Hospital:
Cholangitis
biliary atresia
kasai Portoenterostomy
antibiotics
treatment
Additional relevant MeSH terms:
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Cholangitis
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Liver Diseases
Liver Cirrhosis
Meropenem
Tinidazole
Teicoplanin
Sulperazone
Anti-Bacterial Agents
Anti-Infective Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Urinary
Renal Agents