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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2022-08-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Ascites Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Study design: non inferiority prospective non randomized controlled trial

Study population and setting:

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.

Sample size: 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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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treatment group or Rifaximin group

they received Rifaximin 550 milligram every 12 hour

Group Type EXPERIMENTAL

Rifaximin 550 milligram Oral Tablet [XIFAXAN]

Intervention Type DRUG

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

control group or Norfloxacin group

they received Norfloxacin 400 milligram per day

Group Type ACTIVE_COMPARATOR

Rifaximin 550 milligram Oral Tablet [XIFAXAN]

Intervention Type DRUG

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

Interventions

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Rifaximin 550 milligram Oral Tablet [XIFAXAN]

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

Intervention Type DRUG

Other Intervention Names

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xifaxan

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No