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

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.

Study Overview

• Status: Completed
• Conditions: Spontaneous Bacterial Peritonitis
• Intervention / Treatment: Drug: Rifaximin 550Mg Tab; Diagnostic test: ascitic fluid sample; Drug: Ciprofloxacin 750 MG

Detailed Description

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

The included cases were collected from hepatology outpatient clinic and inpatient department at Ain shams University hospital between May 2023 and November 2023 after the scientific ethical committee approval. A written consent was obtained from the included cases.

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, and HIV patients were all excluded from the trial. Before starting the trial, the all cases were diagnosed as SBP with ascitic fluid sample with polymorphonuclear cell count more than 250 cells /µL and received medical treatment of SBP according to EASL guidelines for treatment of SBP.

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.

All included patients went through a comprehensive medical history, full physical assessment as well as full laboratory examination including; CBC, liver profile (ALT, AST, ALP, GGT, total & direct bilirubin, serum albumin, serum total proteins), kidney function tests (S.creat, BUN), ascitic fluid sample was taken from every patients at the starting of the trial to make sure the recovery from the previous SBP attack (AFS1) and another sample was taken once the patient was suspected to have another attack of SBP or after 6 months of treatment (AFS2). The ascitic samples were subjected to analysis of the differential cell count and measurement of ascitic albumin, glucose, total proteins and LDH, culture and sensitivity were assessed. The Child-Pugh's score were assessed, and pelvi-abdominal ultrasound were done for all patients.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 3753450
    • Mostafa Elfors

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group (1); Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period.	Drug: Rifaximin 550Mg Tab; group (1) received Rifaximin as 550 mg twice daily dosage for six months.; Other Names: gastrobiotic; Diagnostic test: ascitic fluid sample; aspiration of ascitic fluid sample and analysis for differential cell count; Other Names: aspiration of ascitic fluid
Active Comparator: group (2); Group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period.	Diagnostic test: ascitic fluid sample; aspiration of ascitic fluid sample and analysis for differential cell count; Other Names: aspiration of ascitic fluid; Drug: Ciprofloxacin 750 MG; group (2) received Ciprofloxacin 750 mg tab mg once weekly dosage for six months.; Other Names: Cipro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Intraabdominal Infections; Peritonitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Rifaximin; Ciprofloxacin
• Other Study ID Numbers: FMASU R140/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes