NCT04370145|CompletedPhase 4
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Sponsor study identifier
interventional
160
1 country
2
Study Start
May 1, 2021
Actual (reported)Primary Completion
October 1, 2021
Actual (reported)Study Completion
April 1, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2022
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 23, 2020
Actual (reported)April 30, 2020
Actual (reported)May 1, 2021
Actual (reported)October 1, 2021
Actual (reported)April 1, 2022
Actual (reported)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
Recurrence rate
1 year
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
moderate cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.
severe cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.
Tongji hospital affiliated to tongji medical college of huazhong university of science and technology
Wuhan, Hubei, 430030, China
TongjiHospital
Wuhan, Hubei, 430030, China
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.
Feng Jiexiong, Postdoctoral
Tongji Hospital
160 participants (actual enrollment reported by the registry).
First Submitted
April 23, 2020
First Posted
April 30, 2020
"Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)"
cholangitis in control group were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.
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Study Start
May 1, 2021
Actual (reported)Primary Completion
October 1, 2021
Actual (reported)Study Completion
April 1, 2022
Actual (reported)Last Updated
April 11, 2022
Record last verified: 2022-04
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