Clinical trial NCT05621005: Rifaximin Prophylaxis for Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome in Cirrhotic Patients
Official title: Rifaximin Prophylaxis Against Recurrence of Spontaneous Bacterial Peritonitis and Occurrence of Hepatorenal Syndrome in Decompensated Cirrhotic Egyptian Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ascites Infection
Keywords: Rifaximin
Norflixacin
Spontaneous bacterial peritonitis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: secondary prophylaxis of SBP and primary prophylaxis for hepatorenal syndrome
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine Ain Shams university
Study officials:
affiliation: assistant lecturer
name: Samar A Sebaweh, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Acevedo JG, Cramp ME. Hepatorenal syndrome: Update on diagnosis and therapy. World J Hepatol. 2017 Feb 28;9(6):293-299. doi: 10.4254/wjh.v9.i6.293.
citation: Dong T, Aronsohn A, Gautham Reddy K, Te HS. Rifaximin Decreases the Incidence and Severity of Acute Kidney Injury and Hepatorenal Syndrome in Cirrhosis. Dig Dis Sci. 2016 Dec;61(12):3621-3626. doi: 10.1007/s10620-016-4313-0. Epub 2016 Sep 21.
citation: Fernandez J, Tandon P, Mensa J, Garcia-Tsao G. Antibiotic prophylaxis in cirrhosis: Good and bad. Hepatology. 2016 Jun;63(6):2019-31. doi: 10.1002/hep.28330. Epub 2016 Jan 11.
citation: Moreau R, Elkrief L, Bureau C, Perarnau JM, Thevenot T, Saliba F, Louvet A, Nahon P, Lannes A, Anty R, Hillaire S, Pasquet B, Ozenne V, Rudler M, Ollivier-Hourmand I, Robic MA, d'Alteroche L, Di Martino V, Ripault MP, Pauwels A, Grange JD, Carbonell N, Bronowicki JP, Payance A, Rautou PE, Valla D, Gault N, Lebrec D; NORFLOCIR Trial Investigators. Effects of Long-term Norfloxacin Therapy in Patients With Advanced Cirrhosis. Gastroenterology. 2018 Dec;155(6):1816-1827.e9. doi: 10.1053/j.gastro.2018.08.026. Epub 2018 Aug 23.
citation: Soriano G, Guarner C, Teixido M, Such J, Barrios J, Enriquez J, Vilardell F. Selective intestinal decontamination prevents spontaneous bacterial peritonitis. Gastroenterology. 1991 Feb;100(2):477-81. doi: 10.1016/0016-5085(91)90219-b.
citation: Vlachogiannakos J, Viazis N, Vasianopoulou P, Vafiadis I, Karamanolis DG, Ladas SD. Long-term administration of rifaximin improves the prognosis of patients with decompensated alcoholic cirrhosis. J Gastroenterol Hepatol. 2013 Mar;28(3):450-5. doi: 10.1111/jgh.12070.