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

Primary Purpose

Ascites Infection

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Rifaximin 550 milligram Oral Tablet [XIFAXAN]
Sponsored by
Samar Atef Sebaweh Mohammed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ascites Infection focused on measuring Rifaximin, Norflixacin, Spontaneous bacterial peritonitis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • faculty of medicine Ain Shams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

treatment group or Rifaximin group

control group or Norfloxacin group

Arm Description

they received Rifaximin 550 milligram every 12 hour

they received Norfloxacin 400 milligram per day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 12, 2022
Last Updated
November 17, 2022
Sponsor
Samar Atef Sebaweh Mohammed
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1. Study Identification

Unique Protocol Identification Number
NCT05621005
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Samar Atef Sebaweh Mohammed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascites Infection
Keywords
Rifaximin, Norflixacin, Spontaneous bacterial peritonitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment group or Rifaximin group
Arm Type
Experimental
Arm Description
they received Rifaximin 550 milligram every 12 hour
Arm Title
control group or Norfloxacin group
Arm Type
Active Comparator
Arm Description
they received Norfloxacin 400 milligram per day
Intervention Type
Drug
Intervention Name(s)
Rifaximin 550 milligram Oral Tablet [XIFAXAN]
Other Intervention Name(s)
xifaxan
Intervention Description
Rifaximin was given on dose of 550 milligram every 12 hours orally for at least 3 months
Primary Outcome Measure Information:
Title
secondary prophylaxis of SBP and primary prophylaxis for hepatorenal syndrome
Description
our study was conducted to test the efficacy of Rifaximin in prevention of recurrence of SBP and occurrence of hepatorenal syndrome
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samar A Sebaweh, master
Organizational Affiliation
assistant lecturer
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of medicine Ain Shams university
City
Cairo
ZIP/Postal Code
02
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
individual participant data will be shared including inclusion criteria and the final statical results
IPD Sharing Time Frame
3 to 5 months
IPD Sharing Access Criteria
through the official e mail and the publishing journal
Citations:
PubMed Identifier
28293378
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.
Results Reference
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PubMed Identifier
27655104
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.
Results Reference
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PubMed Identifier
26528864
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.
Results Reference
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PubMed Identifier
30144431
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.
Results Reference
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PubMed Identifier
1985045
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.
Results Reference
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PubMed Identifier
23216382
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.
Results Reference
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Rifaximin Prophylaxis for Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome in Cirrhotic Patients

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