drugset / Trial / NCT06827756

Comparative Study of Secondary Prophylaxis for SBP

NCT06827756

Phase 4 Completed 90 enrolled Tanta University
RandomizedParallel-groupOpen-labelPrevention

Summary

The goal of this clinical trial is to learn if norfloxacin, nitazoxanide, and colistin work as secondary prophylactic agents for spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites. It also aims to evaluate the safety and effectiveness of these treatments. The main questions it aims to answer are: Are nitazoxanide and colistin as effective as norfloxacin in preventing recurrent SBP? What medical outcomes do participants experience when taking norfloxacin, nitazoxanide, or colistin? Researchers will compare norfloxacin, nitazoxanide, and colistin to determine their effectiveness in preventing SBP recurrence in cirrhotic patients. Participants will: Be randomly assigned to receive either 400 mg norfloxacin daily, 500 mg nitazoxanide twice daily, or 15 ml colistin syrup three times daily (2.25 MIU total per day). Undergo regular blood tests and ascitic fluid analysis at discharge, 2 months, and 6 months post-treatment. Be monitored for any side effects and recurrence of SBP.

Timeline

Start
2021-03-01
Primary completion
2021-12-01
Completion
2022-02-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Colistin Other / unclassified 15 ml
Comparator Nitazoxanide Other / unclassified 500 mg
Comparator Norfloxacin Small molecule 400 mg