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

NCT05621005 | Completed Phase 2 DMC

• 1 other identifier: SBP prophylaxis
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Ascites Infection

Keywords

Rifaximin; Norflixacin; Spontaneous bacterial peritonitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

treatment group or Rifaximin group

EXPERIMENTAL

they received Rifaximin 550 milligram every 12 hour

Drug: Rifaximin 550 milligram Oral Tablet [XIFAXAN]

control group or Norfloxacin group

ACTIVE COMPARATOR

they received Norfloxacin 400 milligram per day

Drug: Rifaximin 550 milligram Oral Tablet [XIFAXAN]

Interventions

Rifaximin 550 milligram Oral Tablet [XIFAXAN] DRUG

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

Also known as: xifaxan

control group or Norfloxacin group; treatment group or Rifaximin group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samar Atef Sebaweh Mohammed: lead

Study Sites (1)

faculty of medicine Ain Shams university

Cairo, 02, Egypt

Location

Related 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.

  PMID: 28293378 BACKGROUND

• 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.

  PMID: 27655104 BACKGROUND

• 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.

  PMID: 26528864 BACKGROUND

• 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.

  PMID: 30144431 BACKGROUND

• 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.

  PMID: 1985045 BACKGROUND

• 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.

  PMID: 23216382 BACKGROUND

MeSH Terms

Interventions

Rifaximin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Samar A Sebaweh, master

  assistant lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecturer

Model Details: 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 Record Dates

• First Submitted: November 12, 2022
• First Posted: November 17, 2022
• Study Start: March 1, 2019
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 to 5 months
• Access Criteria: through the official e mail and the publishing journal

Locations

EG (1)