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

Sponsor

Samar Atef Sebaweh Mohammed (Other)

Overall Status

Completed

CT.gov ID

NCT05621005

Collaborator

(none)

104

Enrollment

Location

Arms

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ascites Infection	Drug: Rifaximin 550 milligram Oral Tablet [XIFAXAN]	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.Study design: non inferiority prospective non randomized controlled trialStudy 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.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Jul 1, 2022

Actual Study Completion Date :

Aug 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

secondary prophylaxis of SBP and primary prophylaxis for hepatorenal syndrome [3 months]
our study was conducted to test the efficacy of Rifaximin in prevention of recurrence of SBP and occurrence of hepatorenal syndrome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.