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Completed

NCT Number: NCT05621005

Rifaximin Prophylaxis for Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome in Cirrhotic Patients

Norfloxacin is the most commonly used drug for the prophylaxis against spontaneous bacterial peritonitis (SBP) in patients with liver cirrhosis. Rifaximin, another broad spectrum antibiotic with only trivial absorption from the gut, is used for the treatment of traveler's diarrhea and prevention of hepatic encephalopathy.

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

faculty of medicine Ain Shams university

Cairo, 02, Egypt

About this study

Prophylaxis against spontaneous bacterial peritonitis (SBP) in cirrhotic patients recovered from an episode of SBP using Norfloxacin 400 mg/day is currently established standard of care. Recently we are facing the growing challenge of standard SBP prophylaxis lacking efficacy as extended spectrum beta-lactamases and fluoro-quinolone resistant bacteria in isolates of patients on Norfloxacin.

Prophylaxis against Hepatorenal Syndrome in decompensated liver cirrhosis is limited to IV administration of Albumin in patients who develop SBP and the prevention of SBP using Norfloxacin.

this study aims to investigate the effectiveness of Rifaximin in decompensated cirrhotic patients against SBP as a secondary prophylaxis measure and Hepatorenal Syndrome.

our study was non inferiority prospective non randomized controlled trial The study enrolled patients with chronic liver disease and ascites who were monitored at outpatient clinics or who were admitted to Ain Shams University hospitals.104 patients with decompensated liver cirrhosis were enrolled in the study, The Control Group (n=52), to receive standard of care treatment & Norfloxacin prophylaxis for the decompensated liver disease and a second Treatment Group (n=52) who will receive Rifaximin prophylaxis in addition to the original management.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Decompensated cirrhotic patients (Child B or C, ascetic patients).
  • Adult male/female aged >18 years old.
  • History or evidence of previous attack of SBP and currently clinically free from SBP.

Exclusion criteria

  • Recent abdominal surgery.
  • Patients with renal impairment (serum creatinine >1.5mg/dl) at baseline.
  • Patients on renal replacement therapy (RRT) at baseline.
  • Sonographic evidence of Nephropathy other than grade I nephropathy in ascetic patients
  • intraabdominal source of infection (e.g. intra-abdominal abscesses, cholecystitis or acute pancreatitis).
  • Patients with current evidence of upper Urinary tract infection.
  • Other comorbidities affecting the patient survival e.g. significant cardiac disease, pulmonary disease, portal vein thrombosis, hepatocellular carcinoma or other malignancies, etc.
  • Sepsis.
  • Current or recent treatment with nephrotoxic drugs or contrast material injection.

Treatment and study plan

Rifaximin 550 milligram Oral Tablet [XIFAXAN]

Drug

Rifaximin was given on dose of 550 milligram every 12 hours orally for at least 3 months

Other names: xifaxan

Primary outcomes

  1. secondary prophylaxis of SBP and primary prophylaxis for hepatorenal syndrome

    Time frame: 3 months

    our study was conducted to test the efficacy of Rifaximin in prevention of recurrence of SBP and occurrence of hepatorenal syndrome

Sponsors and collaborators

Lead sponsor

Samar Atef Sebaweh Mohammed

Other

Registry information

Official study title

Rifaximin Prophylaxis Against Recurrence of Spontaneous Bacterial Peritonitis and Occurrence of Hepatorenal Syndrome in Decompensated Cirrhotic Egyptian Patients

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2022
Registry last updated
Nov 21, 2022

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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