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

NCT ID: NCT06234046

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-28
• Study Completion Date: 2023-12-15

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.

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.

Conditions

Spontaneous Bacterial Peritonitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

group (1)

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

Group Type: ACTIVE_COMPARATOR

Rifaximin 550Mg Tab

Intervention Type: DRUG

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

ascitic fluid sample

Intervention Type: DIAGNOSTIC_TEST

aspiration of ascitic fluid sample and analysis for differential cell count

group (2)

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

Group Type: ACTIVE_COMPARATOR

Ciprofloxacin 750 MG

Intervention Type: DRUG

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

ascitic fluid sample

Intervention Type: DIAGNOSTIC_TEST

aspiration of ascitic fluid sample and analysis for differential cell count

Interventions

Rifaximin 550Mg Tab

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

Intervention Type: DRUG

Ciprofloxacin 750 MG

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

Intervention Type: DRUG

ascitic fluid sample

aspiration of ascitic fluid sample and analysis for differential cell count

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

gastrobiotic; Cipro; aspiration of ascitic fluid

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mostafa Elfors

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU R140/2023

Identifier Type: -

Identifier Source: org_study_id