Rifaximin as a Prophylaxis of Spontaneous Bacterial Peritonitis in Comparison With Ciprofloxacin
Condition: Spontaneous Bacterial Peritonitis
MeSH terms: Peritonitis
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Rifaximin 550Mg Tab; Ciprofloxacin 750 MG; ascitic fluid sample
Intervention type(s): Drug; Drug; Diagnostic Test
Intervention description(s): group (1) received Rifaximin as 550 mg twice daily dosage for six months.; group (2) received Ciprofloxacin 750 mg tab mg once weekly dosage for six months.; aspiration of ascitic fluid sample and analysis for differential cell count
Other intervention name(s): gastrobiotic; Cipro; aspiration of ascitic fluid
Intervention MeSH terms: Ciprofloxacin; Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Prevention