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

Ascites Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05621005
• Other study ID #: SBP prophylaxis
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2019
• Est. completion date: August 1, 2022

Study information

• Verified date: November 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: August 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ascites
• Ascites Infection
• Hepatorenal Syndrome
• Peritonitis

Intervention

Drug:
• Rifaximin 550 milligram Oral Tablet [XIFAXAN]
Rifaximin was given on dose of 550 milligram every 12 hours orally for at least 3 months

Locations

Country	Name	City	State
Egypt	faculty of medicine Ain Shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Samar Atef Sebaweh Mohammed

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. — View 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. Epub 2016 Sep 21. — View Citation

Fernández 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. Review. — View Citation

Moreau R, Elkrief L, Bureau C, Perarnau JM, Thévenot 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, Grangé JD, Carbonell N, Bronowicki JP, Payancé 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. — View Citation

Soriano G, Guarner C, Teixidó M, Such J, Barrios J, Enríquez J, Vilardell F. Selective intestinal decontamination prevents spontaneous bacterial peritonitis. Gastroenterology. 1991 Feb;100(2):477-81. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	secondary prophylaxis of SBP and primary prophylaxis for hepatorenal syndrome	our study was conducted to test the efficacy of Rifaximin in prevention of recurrence of SBP and occurrence of hepatorenal syndrome	3 months