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

NCT06234046 | Completed Phase 3 FDA Drug FDA Device

• 1 other identifier: FMASU R140/2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The efficacy of Rifaximin as a prophylactic treatment for SBP.

  comparison between Rifaximin and Ciprofloxacin when used as a prophylaxis for the recurrence of SBP.

  All patients of the two groups were followed up for 6 months.

Study Arms (2)

group (1)

ACTIVE COMPARATOR

Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period.

Drug: Rifaximin 550Mg Tab; Diagnostic Test: ascitic fluid sample

group (2)

ACTIVE COMPARATOR

Group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period.

Drug: Ciprofloxacin 750 MG; Diagnostic Test: ascitic fluid sample

Interventions

Rifaximin 550Mg Tab DRUG

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

Also known as: gastrobiotic

group (1)

Ciprofloxacin 750 MG DRUG

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

Also known as: Cipro

group (2)

ascitic fluid sample DIAGNOSTIC_TEST

aspiration of ascitic fluid sample and analysis for differential cell count

Also known as: aspiration of ascitic fluid

group (1); group (2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cirrhotic liver disease patients with ascites just recovered from SBP attack.
• Must be able to swallow tablets

You may not qualify if:

• Cases with metastatic HCC.
• patients with drug allergy from Ciprofloxacin or Rifaximin.
• those having ascites secondary to other causes rather than liver cirrhosis.
• those having gastroenterology malignancy.
• patients on immunotherapy.
• HIV patients.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Mostafa Elfors

Cairo, 3753450, Egypt

Location

MeSH Terms

Interventions

Rifaximin; Ciprofloxacin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This randomized controlled trial was performed on two groups of Egyptian patients diagnosed with cirrhotic liver disease and ascites just recovered from SBP attack, group (1) included 40 patients were administered Rifaximin as 550 mg twice daily dosage for six months and group (2)included 40 patients were administered Ciprofloxacin as 750 mg once weekly dose for 6 months. All patients of the two groups were followed up for recurrence of SBP for 6 months.

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 31, 2024
• Study Start: May 28, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 15, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

EG (1)