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Completed

NCT Number: NCT06234046

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mostafa Elfors

Cairo, 3753450, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rifaximin 550Mg Tab

Drug

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

Other names: gastrobiotic

Ciprofloxacin 750 MG

Drug

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

Other names: Cipro

ascitic fluid sample

Diagnostic Test

aspiration of ascitic fluid sample and analysis for differential cell count

Other names: aspiration of ascitic fluid

Primary outcomes

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

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

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2024
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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