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
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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