Cholangitis, Secondary BiliaryPhase 4NCT04370145
Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy
A Phase 4 study testing Sulperazon, Teicoplanin and Meropenem Injection in people with Cholangitis, Secondary Biliary and Treatment Compliance, run by Tongji Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 2 years
- Conditions the study is for
- Cholangitis, Secondary Biliary, Treatment Compliance, Antibodies Drug Specific
- What is being tested?
- Sulperazon, Teicoplanin and Meropenem Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2021to 1 Apr 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Tongji hospital affiliated to tongji medical college of huazhong university of science and technology
Wuhan, Hubei, 430030
TongjiHospital
Wuhan, Hubei, 430030
About this study
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.
Read the 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.
- Being tested
- Sulperazon, Teicoplanin, Meropenem Injection
- Keywords
- Cholangitis, biliary atresia, kasai Portoenterostomy, antibiotics, treatment
- Medical subject headings
- Liver Cirrhosis, Biliary, Patient Compliance, Cholangitis, Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulperazonDrug
Also called Tinidazole injection
moderate cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.
TeicoplaninDrug
Also called Meropenem Injection, Tinidazole injection
severe cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.
Meropenem InjectionDrug
Also called Tinidazole injection
cholangitis in control group were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.
| Study group | Role | What they receive |
|---|---|---|
| moderate cholangitis | Experimental | Meropenem injection, iv. drip,20mg/Kg，Q12h; Tinidazole injection, iv. drip,20mg/Kg,Qd. Receives: 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. Receives: Drug: Teicoplanin |
| control group | Active comparator | Sulperazon, iv.,drip,100mg/Kg,Bid; Tinidazole injection, iv. drip,20mg/Kg,Qd Receives: Drug: Meropenem Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (1)
Recurrence rate
To collect recurrent episode of cholangitis and recurrent rate of each group.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start1 May 2021
- Primary completion1 Oct 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholangitis, Secondary BiliaryStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Children's Hospital
- Responsible party
- Principal investigator, J.X. Feng, Tongji Hospital
- Investigators
- Feng Jiexiong, Postdoctoral, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370145
- Sponsor's protocol ID
- JXFeng
- Status last verified
- Apr 2022
- First submitted
- 23 Apr 2020
- Last updated
- 11 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37678274
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy
- ClinicalTrials.gov ID
- NCT04370145
- Acronym / sponsor ID
- JXFeng
- Keywords
- Cholangitis, biliary atresia, kasai Portoenterostomy, antibiotics, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Shanghai Children's Hospital
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| moderate cholangitis | Experimental | Drug: SulperazonMeropenem injection, iv. drip,20mg/Kg，Q12h; Tinidazole injection, iv. drip,20mg/Kg,Qd. |
| severe cholangitis | Experimental | Drug: TeicoplaninMeropenem injection, iv. drip,20mg/Kg，Q8h; Teicoplanin injection, iv. drip,10mg/Kg,Qd; Tinidazole injection, iv. drip,20mg/Kg,Qd. |
| control group | Active comparator | Drug: Meropenem InjectionSulperazon, iv.,drip,100mg/Kg,Bid; Tinidazole injection, iv. drip,20mg/Kg,Qd |
Who may qualify
- Ages
- 3 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SulperazonAlso: Tinidazole injectionmoderate cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic. | Drug | moderate cholangitis |
| TeicoplaninAlso: Meropenem Injection, Tinidazole injectionsevere cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic. | Drug | severe cholangitis |
| Meropenem InjectionAlso: Tinidazole injectioncholangitis in control group were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic. | Drug | control group |
Primary outcome
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.
1 secondary outcome
Recurrence rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Derived from this study: PubMed 37678274Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng Jiexiong, Postdoctoral principal investigator
Tongji Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sulperazon, Teicoplanin and Meropenem Injection in people with Cholangitis, Secondary Biliary and Treatment Compliance, run by Tongji Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery rate (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04370145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.