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Comparative Study of Secondary Prophylaxis for SBP

NCT06827756 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-02-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06827756 on ClinicalTrials.gov