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

November 17, 2022 updated by: Samar Atef Sebaweh Mohammed

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • Faculty of medicine ain shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group or Rifaximin group
they received Rifaximin 550 milligram every 12 hour
Drug: Rifaximin 550 milligram Oral Tablet [XIFAXAN]
Rifaximin was given on dose of 550 milligram every 12 hours orally for at least 3 months
Other Names:
  • xifaxan
Active Comparator: control group or Norfloxacin group
they received Norfloxacin 400 milligram per day
Drug: Rifaximin 550 milligram Oral Tablet [XIFAXAN]
Rifaximin was given on dose of 550 milligram every 12 hours orally for at least 3 months
Other Names:
  • xifaxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samar Atef Sebaweh Mohammed

Investigators

  • Principal Investigator: Samar A Sebaweh, master, assistant lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

November 12, 2022

First Submitted That Met QC Criteria

November 12, 2022

First Posted (Actual)

November 17, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBP prophylaxis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

individual participant data will be shared including inclusion criteria and the final statical results

IPD Sharing Time Frame

3 to 5 months

IPD Sharing Access Criteria

through the official e mail and the publishing journal

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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