Rifaximin as a Prophylaxis of Spontaneous Bacterial Peritonitis in Comparison With Ciprofloxacin

NCT06234046 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-01-31

No results posted yet for this study

Summary

The goal of this Randomized controlled trial is to assessment the efficacy of Rifaximin as a prophylaxis of SBP in comparison with ciprofloxacin in Egyptian patients.

This randomized controlled trial included 80 Egyptian patients diagnosed with cirrhotic liver disease and ascites just recovered from SBP attack grouped into two groups as; Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period and group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period.

All patients of the two groups were followed up for recurrence of SBP for 6 months. The study endpoints would be SBP, death, compliance failure, or liver transplantation.

Conditions

  • Spontaneous Bacterial Peritonitis

Interventions

DRUG

Rifaximin 550Mg Tab

group (1) received Rifaximin as 550 mg twice daily dosage for six months.

DRUG

Ciprofloxacin 750 MG

group (2) received Ciprofloxacin 750 mg tab mg once weekly dosage for six months.

DIAGNOSTIC_TEST

ascitic fluid sample

aspiration of ascitic fluid sample and analysis for differential cell count

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-28
Primary Completion
2023-11-30
Completion
2023-12-15
FDA Drug
Yes
FDA Device
Yes

Countries

  • Egypt

Study Locations

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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 NCT06234046 on ClinicalTrials.gov