NCT06827756

Comparative Study of Secondary Prophylaxis for SBP

Comparative Study Between Norfloxacin, Nitazoxanide and Colistin As Secondary Prophylactic Agents for Spontaneous Bacterial Peritonitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spontaneous Bacterial Peritonitis
• Cirrhoses, Liver
• Ascites

Interventions

Type	Name	Description
DRUG	Norfloxacin 400 MG	Patients receiving Norfloxacin 400 Mg to prevent SBP
DRUG	Nitazoxanide 500 MG	Patients receiving Nitazoxaide 500 Mg to prevent SBP
DRUG	Colistin	Patients receiving Colistin 15ml three times/ day to prevent SBP

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-12-01
• Completion: 2022-02-01
• First posted: 2025-02-14
• Last updated: 2025-02-14

Locations

1 site across 1 country: Egypt