Nctid:
NCT06234046
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010538", "term"=>"Peritonitis"}], "ancestors"=>[{"id"=>"D000059413", "term"=>"Intraabdominal Infections"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000010532", "term"=>"Peritoneal Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}], "browseLeaves"=>[{"id"=>"M13447", "name"=>"Peritonitis", "asFound"=>"Peritonitis", "relevance"=>"HIGH"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M29465", "name"=>"Intraabdominal Infections", "relevance"=>"LOW"}, {"id"=>"M13441", "name"=>"Peritoneal Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000002939", "term"=>"Ciprofloxacin"}, {"id"=>"D000078262", "term"=>"Rifaximin"}], "ancestors"=>[{"id"=>"D000000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000059005", "term"=>"Topoisomerase II Inhibitors"}, {"id"=>"D000059003", "term"=>"Topoisomerase Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000065609", "term"=>"Cytochrome P-450 CYP1A2 Inhibitors"}, {"id"=>"D000065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D000005765", "term"=>"Gastrointestinal Agents"}], "browseLeaves"=>[{"id"=>"M1946", "name"=>"Rifaximin", "asFound"=>"Hypertensive", "relevance"=>"HIGH"}, {"id"=>"M6176", "name"=>"Ciprofloxacin", "asFound"=>"Defect", "relevance"=>"HIGH"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M29348", "name"=>"Topoisomerase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M8881", "name"=>"Gastrointestinal Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE", "maskingDescription"=>"no masking"}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"This randomized controlled trial was performed on two groups of Egyptian patients diagnosed with cirrhotic liver disease and ascites just recovered from SBP attack, group (1) included 40 patients were administered Rifaximin as 550 mg twice daily dosage for six months and group (2)included 40 patients were administered Ciprofloxacin as 750 mg once weekly dose for 6 months. All patients of the two groups were followed up for recurrence of SBP for 6 months."}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>80}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-05-28", "type"=>"ACTUAL"}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-12-15", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-29", "studyFirstSubmitDate"=>"2024-01-09", "studyFirstSubmitQcDate"=>"2024-01-29", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-11-30", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The efficacy of Rifaximin as a prophylactic treatment for SBP.", "timeFrame"=>"All patients of the two groups were followed up for 6 months.", "description"=>"comparison between Rifaximin and Ciprofloxacin when used as a prophylaxis for the recurrence of SBP."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"conditions"=>["Spontaneous Bacterial Peritonitis"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this Randomized controlled trial is to assessment the efficacy of Rifaximin as a prophylaxis of SBP in comparison with ciprofloxacin in Egyptian patients.\n\nThis randomized controlled trial included 80 Egyptian patients diagnosed with cirrhotic liver disease and ascites just recovered from SBP attack grouped into two groups as; Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period and group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period.\n\nAll patients of the two groups were followed up for recurrence of SBP for 6 months. The study endpoints would be SBP, death, compliance failure, or liver transplantation.", "detailedDescription"=>"This randomized controlled trial included 80 Egyptian patients diagnosed with cirrhotic liver disease and ascites just recovered from SBP attack grouped into two groups as;\n\n* Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period.\n* Group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period.\n\nThe included cases were collected from hepatology outpatient clinic and inpatient department at Ain shams University hospital between May 2023 and November 2023 after the scientific ethical committee approval. A written consent was obtained from the included cases.\n\nCases with metastatic HCC, patients with drug allergy from Ciprofloxacin or Rifaximin, those having ascites secondary to other causes rather than liver cirrhosis, those having gastroenterology malignancy, patients on immunotherapy, and HIV patients were all excluded from the trial. Before starting the trial, the all cases were diagnosed as SBP with ascitic fluid sample with polymorphonuclear cell count more than 250 cells /µL and received medical treatment of SBP according to EASL guidelines for treatment of SBP.\n\nAll patients of the two groups were followed up for recurrence of SBP for 6 months. The study endpoints would be SBP, death, compliance failure, or liver transplantation.\n\nAll included patients went through a comprehensive medical history, full physical assessment as well as full laboratory examination including; CBC, liver profile (ALT, AST, ALP, GGT, total \\& direct bilirubin, serum albumin, serum total proteins), kidney function tests (S.creat, BUN), ascitic fluid sample was taken from every patients at the starting of the trial to make sure the recovery from the previous SBP attack (AFS1) and another sample was taken once the patient was suspected to have another attack of SBP or after 6 months of treatment (AFS2). The ascitic samples were subjected to analysis of the differential cell count and measurement of ascitic albumin, glucose, total proteins and LDH, culture and sensitivity were assessed. The Child-Pugh's score were assessed, and pelvi-abdominal ultrasound were done for all patients."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* cirrhotic liver disease patients with ascites just recovered from SBP attack.\n* Must be able to swallow tablets\n\nExclusion Criteria:\n\n* Cases with metastatic HCC.\n* patients with drug allergy from Ciprofloxacin or Rifaximin.\n* those having ascites secondary to other causes rather than liver cirrhosis.\n* those having gastroenterology malignancy.\n* patients on immunotherapy.\n* HIV patients."}, "identificationModule"=>{"nctId"=>"NCT06234046", "briefTitle"=>"Rifaximin as a Prophylaxis of Spontaneous Bacterial Peritonitis in Comparison With Ciprofloxacin", "organization"=>{"class"=>"OTHER", "fullName"=>"Ain Shams University"}, "officialTitle"=>"Rifaximin as a Prophylaxis of Spontaneous Bacterial Peritonitis in Comparison With Ciprofloxacin", "orgStudyIdInfo"=>{"id"=>"FMASU R140/2023"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"group (1)", "description"=>"Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period.", "interventionNames"=>["Drug: Rifaximin 550Mg Tab", "Diagnostic Test: ascitic fluid sample"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"group (2)", "description"=>"Group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period.", "interventionNames"=>["Drug: Ciprofloxacin 750 MG", "Diagnostic Test: ascitic fluid sample"]}], "interventions"=>[{"name"=>"Rifaximin 550Mg Tab", "type"=>"DRUG", "otherNames"=>["gastrobiotic"], "description"=>"group (1) received Rifaximin as 550 mg twice daily dosage for six months.", "armGroupLabels"=>["group (1)"]}, {"name"=>"Ciprofloxacin 750 MG", "type"=>"DRUG", "otherNames"=>["Cipro"], "description"=>"group (2) received Ciprofloxacin 750 mg tab mg once weekly dosage for six months.", "armGroupLabels"=>["group (2)"]}, {"name"=>"ascitic fluid sample", "type"=>"DIAGNOSTIC_TEST", "otherNames"=>["aspiration of ascitic fluid"], "description"=>"aspiration of ascitic fluid sample and analysis for differential cell count", "armGroupLabels"=>["group (1)", "group (2)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"3753450", "city"=>"Cairo", "country"=>"Egypt", "facility"=>"Mostafa Elfors", "geoPoint"=>{"lat"=>30.06263, "lon"=>31.24967}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Ain Shams University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
