Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT05621005
Status:
COMPLETED
Last Update Posted:
2022-11-21
First Post:
2022-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rifaximin Prophylaxis for Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome in Cirrhotic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078262', 'term': 'Rifaximin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study design: non inferiority prospective non randomized controlled trial\n\nStudy population and setting:\n\nThe study enrolled patients with chronic liver disease and ascites who were monitored at outpatient clinics or who were admitted to Ain Shams University hospitals.\n\nSample 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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-17', 'studyFirstSubmitDate': '2022-11-12', 'studyFirstSubmitQcDate': '2022-11-12', 'lastUpdatePostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'secondary prophylaxis of SBP and primary prophylaxis for hepatorenal syndrome', 'timeFrame': '3 months', 'description': 'our study was conducted to test the efficacy of Rifaximin in prevention of recurrence of SBP and occurrence of hepatorenal syndrome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rifaximin', 'Norflixacin', 'Spontaneous bacterial peritonitis'], 'conditions': ['Ascites Infection']}, 'referencesModule': {'references': [{'pmid': '28293378', 'type': 'BACKGROUND', '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.'}, {'pmid': '27655104', 'type': 'BACKGROUND', '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.'}, {'pmid': '26528864', 'type': 'BACKGROUND', '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.'}, {'pmid': '30144431', 'type': 'BACKGROUND', '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."}, {'pmid': '1985045', 'type': 'BACKGROUND', '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.'}, {'pmid': '23216382', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nProphylaxis 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.\n\nthis study aims to investigate the effectiveness of Rifaximin in decompensated cirrhotic patients against SBP as a secondary prophylaxis measure and Hepatorenal Syndrome.\n\nour 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Decompensated cirrhotic patients (Child B or C, ascetic patients).\n2. Adult male/female aged \\>18 years old.\n3. History or evidence of previous attack of SBP and currently clinically free from SBP.\n\nExclusion Criteria:\n\n1. Recent abdominal surgery.\n2. Patients with renal impairment (serum creatinine \\>1.5mg/dl) at baseline.\n3. Patients on renal replacement therapy (RRT) at baseline.\n4. Sonographic evidence of Nephropathy other than grade I nephropathy in ascetic patients\n5. intraabdominal source of infection (e.g. intra-abdominal abscesses, cholecystitis or acute pancreatitis).\n6. Patients with current evidence of upper Urinary tract infection.\n7. Other comorbidities affecting the patient survival e.g. significant cardiac disease, pulmonary disease, portal vein thrombosis, hepatocellular carcinoma or other malignancies, etc.\n8. Sepsis.\n9. Current or recent treatment with nephrotoxic drugs or contrast material injection.'}, 'identificationModule': {'nctId': 'NCT05621005', 'briefTitle': 'Rifaximin Prophylaxis for Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome in Cirrhotic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Rifaximin Prophylaxis Against Recurrence of Spontaneous Bacterial Peritonitis and Occurrence of Hepatorenal Syndrome in Decompensated Cirrhotic Egyptian Patients', 'orgStudyIdInfo': {'id': 'SBP prophylaxis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment group or Rifaximin group', 'description': 'they received Rifaximin 550 milligram every 12 hour', 'interventionNames': ['Drug: Rifaximin 550 milligram Oral Tablet [XIFAXAN]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group or Norfloxacin group', 'description': 'they received Norfloxacin 400 milligram per day', 'interventionNames': ['Drug: Rifaximin 550 milligram Oral Tablet [XIFAXAN]']}], 'interventions': [{'name': 'Rifaximin 550 milligram Oral Tablet [XIFAXAN]', 'type': 'DRUG', 'otherNames': ['xifaxan'], 'description': 'Rifaximin was given on dose of 550 milligram every 12 hours orally for at least 3 months', 'armGroupLabels': ['control group or Norfloxacin group', 'treatment group or Rifaximin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'faculty of medicine Ain Shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Samar A Sebaweh, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'assistant lecturer'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '3 to 5 months', 'ipdSharing': 'YES', 'description': 'individual participant data will be shared including inclusion criteria and the final statical results', 'accessCriteria': 'through the official e mail and the publishing journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samar Atef Sebaweh Mohammed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Samar Atef Sebaweh Mohammed', 'investigatorAffiliation': 'Ain Shams University'}}}}