Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-30 @ 2:30 PM
Study NCT ID:
NCT06827756
Status:
COMPLETED
Last Update Posted:
2025-02-14
First Post:
2025-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Secondary Prophylaxis for SBP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001201', 'term': 'Ascites'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009643', 'term': 'Norfloxacin'}, {'id': 'C041747', 'term': 'nitazoxanide'}, {'id': 'D003091', 'term': 'Colistin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011113', 'term': 'Polymyxins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D023181', 'term': 'Antimicrobial Cationic Peptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000089882', 'term': 'Antimicrobial Peptides'}, {'id': 'D052899', 'term': 'Pore Forming Cytotoxic Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events (Safety Assessment)', 'timeFrame': 'Throughout study duration (0-6 months)', 'description': 'Definition: Frequency and severity of treatment-related side effects (e.g., diarrhea, nephrotoxicity, hypersensitivity reactions).\n\nMeasurement: Patient-reported symptoms and clinical examination findings.'}], 'primaryOutcomes': [{'measure': 'Recurrence of Spontaneous Bacterial Peritonitis (SBP)', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': 'Definition: The percentage of patients experiencing a recurrence of SBP within 6 months of treatment initiation.\n\nMeasurement: Diagnosis confirmed by ascitic fluid analysis (PMN count \\> 250 cells/mm³ and positive culture).'}], 'secondaryOutcomes': [{'measure': 'C-Reactive Protein (CRP) Reduction', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months', 'description': 'Definition: A decrease in CRP levels, indicating a reduction in systemic inflammation.\n\nMeasurement: CRP levels measured in mg/L.\n\nSuccess Criteria: A ≥50% reduction in CRP within 3 months is considered a positive response.'}, {'measure': 'White Blood Cell (WBC) Count Reduction', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months', 'description': 'Definition: Reduction in WBC count as a marker of infection control.\n\nMeasurement: WBC count measured in x10³/µL.\n\nSuccess Criteria: A return to normal WBC count (\\<10,000/µL) by 3 months.'}, {'measure': 'Renal Function Stability', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': 'Definition: Prevention of renal impairment during treatment.\n\nMeasurement: Serum Creatinine (mg/dL) and Blood Urea Nitrogen (BUN) (mg/dL).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spontaneous Bacterial Peritonitis', 'Cirrhoses, Liver', 'Ascites']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if norfloxacin, nitazoxanide, and colistin work as secondary prophylactic agents for spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites. It also aims to evaluate the safety and effectiveness of these treatments. The main questions it aims to answer are:\n\nAre nitazoxanide and colistin as effective as norfloxacin in preventing recurrent SBP?\n\nWhat medical outcomes do participants experience when taking norfloxacin, nitazoxanide, or colistin?\n\nResearchers will compare norfloxacin, nitazoxanide, and colistin to determine their effectiveness in preventing SBP recurrence in cirrhotic patients.\n\nParticipants will:\n\nBe randomly assigned to receive either 400 mg norfloxacin daily, 500 mg nitazoxanide twice daily, or 15 ml colistin syrup three times daily (2.25 MIU total per day).\n\nUndergo regular blood tests and ascitic fluid analysis at discharge, 2 months, and 6 months post-treatment.\n\nBe monitored for any side effects and recurrence of SBP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSuccess Criteria: A ≥50% reduction in CRP within 3 months is considered a positive response.\n\n* Ascitic patients diagnosed with Spontaneous Bacterial Peritonitis (SBP) by paracentesis.\n* Ascitic fluid polymorphonuclear (PMN) cell count \\> 250/mm³.\n* Age 50 years to 80 years.\n* Willing to provide informed consent.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding females.\n* History of allergic reactions to Norfloxacin, Nitazoxanide, or Colistin.\n* Patients with recurrent spontaneous peritonitis.\n* Presence of gastrointestinal hemorrhage.\n* Renal failure (Creatinine \\> 2 mg/dL or on dialysis).\n* Presence of severe infection-related sequelae (e.g., persistent fever, abdominal discomfort, sepsis).'}, 'identificationModule': {'nctId': 'NCT06827756', 'acronym': '3C-SPS', 'briefTitle': 'Comparative Study of Secondary Prophylaxis for SBP', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparative Study Between Norfloxacin, Nitazoxanide and Colistin As Secondary Prophylactic Agents for Spontaneous Bacterial Peritonitis', 'orgStudyIdInfo': {'id': '33045/04/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Norfloaxcin arm', 'description': 'patients to receive norflxacin 400mg daily', 'interventionNames': ['Drug: Norfloxacin 400 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nitazoxaide arm', 'description': 'patients to receive nitazoxaide 500mg daily', 'interventionNames': ['Drug: Nitazoxanide 500 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Colisitn arm', 'description': 'patients to receive Colistin 15 ml three times daily, totalling 2,25 MIU/ day', 'interventionNames': ['Drug: Colistin']}], 'interventions': [{'name': 'Norfloxacin 400 MG', 'type': 'DRUG', 'description': 'Patients receiving Norfloxacin 400 Mg to prevent SBP', 'armGroupLabels': ['Norfloaxcin arm']}, {'name': 'Nitazoxanide 500 MG', 'type': 'DRUG', 'description': 'Patients receiving Nitazoxaide 500 Mg to prevent SBP', 'armGroupLabels': ['Nitazoxaide arm']}, {'name': 'Colistin', 'type': 'DRUG', 'description': 'Patients receiving Colistin 15ml three times/ day to prevent SBP', 'armGroupLabels': ['Colisitn arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta University, Faculty of Medicine', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Dina Ahmed Esmat', 'investigatorAffiliation': 'Tanta University'}}}}