drugset / Trial / NCT05925309
Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy
RandomizedParallel-groupSingle-blindPrevention
Summary
This study is non-inferiority trial design. This study aimed to investigate the effect of prophylactic oral antibiotics on preventing cholangitis in biliary atresia (BA) patients after Kasai portoenterostomy (KP) by comparing the cholangitis rate in BA patients who received prophylactic oral antibiotics and those who did not. The patients were followed up for 2 years after KP.
Timeline
- Start
- 2023-07-01
- Primary completion
- 2027-12-31
- Completion
- 2029-12-31
Publications
- Background Calinescu AM, Madadi-Sanjani O, Mack C, Schreiber RA, Superina R, Kelly D, Petersen C, Wildhaber BE. Cholangitis Definition and Treatment after Kasai Hepatoportoenterostomy for Biliary Atresia: A Delphi Process and International Expert Panel. J Clin Med. 2022 Jan 19;11(3):494. doi: 10.3390/jcm11030494.
- Background Chen G, Liu J, Huang Y, Wu Y, Lu X, Dong R, Shen Z, Sun S, Jiang J, Zheng S. Preventive effect of prophylactic intravenous antibiotics against cholangitis in biliary atresia: a randomized controlled trial. Pediatr Surg Int. 2021 Aug;37(8):1089-1097. doi: 10.1007/s00383-021-04916-z. Epub 2021 May 19.
- Background Decharun K, Leys CM, West KW, Finnell SM. Prophylactic Antibiotics for Prevention of Cholangitis in Patients With Biliary Atresia Status Post-Kasai Portoenterostomy: A Systematic Review. Clin Pediatr (Phila). 2016 Jan;55(1):66-72. doi: 10.1177/0009922815594760. Epub 2015 Jul 15.
- Background Vangay P, Ward T, Gerber JS, Knights D. Antibiotics, pediatric dysbiosis, and disease. Cell Host Microbe. 2015 May 13;17(5):553-64. doi: 10.1016/j.chom.2015.04.006.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CEFACLOR ANHYDROUS | Small molecule | 12.5 mg/kg | Oral |
| Comparator | compound sulfamethoxazole | Unknown | 25 mg/kg | Oral |
| Background | IMIPENEM ANHYDROUS | Small molecule | — | Intravenous |
| Background | Meropenem | Small molecule | — | Intravenous |
| Background | Methylprednisolone | Other / unclassified | 4 mg/kg | Intravenous |
| Background | Ursodeoxycholic Acid | Small molecule | 20 mg/kg | Oral |
| Background | compound glycyrrhizin | Unknown | 12.5 mg | Intravenous |
| Background | sulperazone | Unknown | 50 mg/kg | Intravenous |
| Background | vitamin AD , D , E , K | Unknown | — | Oral |