Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-28 @ 10:35 PM
Study NCT ID:
NCT03395405
Status:
COMPLETED
Last Update Posted:
2025-05-21
First Post:
2018-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
NNITS-Nitazoxanide for Norovirus in Transplant Patients Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C041747', 'term': 'nitazoxanide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mgison@northwestern.edu', 'phone': '3126954186', 'title': 'Michael G Ison', 'organization': 'Northwestern University Feinberg School of Medicine'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '180 days', 'eventGroups': [{'id': 'EG000', 'title': 'Nitazoxanide (500 mg)', 'description': 'A single 500 mg tablet of nitazoxanide administered orally twice daily with food for 56 consecutive doses over 28 days.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 12, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'A single matching placebo tablet administered orally twice daily with food for 56 consecutive doses over 28 days.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'deathsNumAffected': 2, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood Alkaline Phosphatase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood Bilirubin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood Creatinine Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood Urea Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemoglobin Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Platelet Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'White Blood Cell Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'White Blood Cell Count Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Hypoxic Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Uremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Initial Clinical Resolution of Norovirus Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (500 mg)', 'description': 'A single 500 mg tablet of nitazoxanide administered orally twice daily with food for 56 consecutive doses over 28 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single matching placebo tablet administered orally twice daily with food for 56 consecutive doses over 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '31'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '14'}]}]}], 'analyses': [{'pValue': '0.459', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.33', 'ciUpperLimit': '1.64', 'pValueComment': 'No adjustment for multiple comparisons was made. The a priori threshold for statistical significant is 0.05.', 'estimateComment': 'HR estimated from a Cox model', 'groupDescription': 'The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.', 'statisticalMethod': 'Likelihood Ratio Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.'}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours through Day 180', 'description': "Time (in days) from randomization until the study day when clinical resolution occurred. Clinical resolution was assessed from participant's daily diaries and was defined as cessation of vomiting and no stools classified by the Bristol Stool Chart as diarrhea (Type 6 or 7) for at least 48 hours.", 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-Treat (mITT) Population: The mITT population included all randomized participants who received at least one dose of assigned study drug. Analyses were performed according to randomized treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Laboratory Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (500 mg)', 'description': 'A single 500 mg tablet of nitazoxanide administered orally twice daily with food for 56 consecutive doses over 28 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single matching placebo tablet administered orally twice daily with food for 56 consecutive doses over 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (baseline) through Day 60', 'description': 'Participants experiencing at least one new laboratory adverse event. Laboratory parameters include White Blood Cell (WBC), Hemoglobin, Platelet Count, Creatinine, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Blood Urea Nitrogen (BUN), and Bilirubin. Laboratory results were considered AEs using the following thresholds : WBC greater than the upper limit of normal (ULN), hemoglobin less than the lower limit of normal (LLN), platelet count less than the LLN; creatinine greater than the ULN; alkaline phosphatase greater than the ULN; ALT greater than the ULN, AST greater than the ULN, BUN greater than or equal to the ULN, and bilirubin greater than the ULN. ULN and LLN values differed by site, sex, and age category.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: The safety population includes all participants who were randomized and received at least one dose of study treatment. Analyses are performed according to treatment received.'}, {'type': 'SECONDARY', 'title': 'Change in Viral Titer (Day 1 to Day 180)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (500 mg)', 'description': 'A single 500 mg tablet of nitazoxanide administered orally twice daily with food for 56 consecutive doses over 28 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single matching placebo tablet administered orally twice daily with food for 56 consecutive doses over 28 days.'}], 'classes': [{'title': 'Norovirus GII', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'Norovirus GI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.4', 'spread': '3.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.735', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustment for multiple comparisons was made. The a priori threshold for statistical significant is 0.05.', 'groupDescription': 'Includes participants in the Norovirus GII subgroup. The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Titer values were log-transformed'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (baseline) and Day 180', 'description': 'Change in viral titer defined as the difference between the Day 180 viral titer and the Day 1 viral titer. Participants were analyzed for the viral load test type (Norovirus GII or Norovirus GI) that they tested positive for at baseline (Day 1).', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-Treat (mITT) Population: The mITT population included all randomized participants who received at least one dose of assigned study drug. Only participants with results at Days 1 and 180 were included. No participants in Placebo GI subgroup had results at both days. Analyses were performed based on randomized treatment assignment. Fewer than 5 participants per treatment arm tested positive for Norovirus GI at baseline thus no GI specific statistical analyses were conducted.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (500 mg)', 'description': 'A single 500 mg tablet of nitazoxanide administered orally twice daily with food for 56 consecutive doses over 28 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single matching placebo tablet administered orally twice daily with food for 56 consecutive doses over 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (baseline) through Day 60', 'description': 'Hospitalizations included any admission to a hospital for treatment and were not reported as Serious Adverse Events (SAEs).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: The safety population includes all participants who were randomized and received at least one dose of study treatment. Analyses are performed according to treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Protocol-Specified SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (500 mg)', 'description': 'A single 500 mg tablet of nitazoxanide administered orally twice daily with food for 56 consecutive doses over 28 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single matching placebo tablet administered orally twice daily with food for 56 consecutive doses over 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (baseline) through Day 60', 'description': 'Protocol-specified SAEs included any adverse event or suspected adverse reaction which, in the view of the investigator or sponsor, resulted in any of the following: death, life threatening adverse event, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life function, congenital anomaly or birth defect, or an important medical event that may jeopardize the participant and require medical or surgical intervention. Hospitalizations were collected as a secondary outcome measure and were not reported as SAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: The safety population includes all participants who were randomized and received at least one dose of study treatment. Analyses are performed according to treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Unsolicited Non-Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (500 mg)', 'description': 'A single 500 mg tablet of nitazoxanide administered orally twice daily with food for 56 consecutive doses over 28 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single matching placebo tablet administered orally twice daily with food for 56 consecutive doses over 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (baseline) through Day 60', 'description': 'Unsolicited adverse events were defined as any non-serious clinical adverse events that were not collected as clinical outcome measures and resulted in either modification in the administration of study drug or discontinuation of the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Unsolicited adverse events were defined as any non-serious clinical adverse events that were not collected as clinical outcome measures and resulted in either modification in the administration of study drug or discontinuation of the study drug.'}, {'type': 'SECONDARY', 'title': 'Time to First Negative Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitazoxanide (500 mg)', 'description': 'A single 500 mg tablet of nitazoxanide administered orally twice daily with food for 56 consecutive doses over 28 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single matching placebo tablet administered orally twice daily with food for 56 consecutive doses over 28 days.'}], 'classes': [{'title': 'Norovirus GII', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Estimates were not calculable due to an insufficient number of participants (less than 50% of participants/treatment group) having a negative viral load.', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Estimates were not calculable due to an insufficient number of participants (less than 50% of participants/treatment group) having a negative viral load.', 'groupId': 'OG001', 'lowerLimit': '120', 'upperLimit': 'NA'}]}]}, {'title': 'Norovirus GI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Estimates were not calculable due to an insufficient number of participants (less than 50% of participants/treatment group) having a negative viral load.', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': 'NA'}, {'value': '22', 'comment': 'Estimates were not calculable due to an insufficient number of participants (less than 50% of participants/treatment group) having a negative viral load.', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.873', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.19', 'ciUpperLimit': '4.06', 'pValueComment': 'No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.', 'groupDescription': 'Includes participants in the Norovirus GII subgroup. The null hypothesis is that there is no difference in time until first negative viral load between study arms, with a two-sided alternative.', 'statisticalMethod': 'Likelihood Ratio Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 (baseline) and Day 180', 'description': 'Time (in days) from randomization until the first study day the participant had either a negative result or a result less than the lower limit of quantitation (LLOQ) for the viral load test type (Norovirus GII or Norovirus GI) that they initially tested positive for at baseline. Participants were analyzed for the viral load test type (Norovirus GII or Norovirus GI) that they tested positive for at baseline (Day 1).', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-Treat (mITT) Population: The mITT population included all randomized participants who received at least one dose of assigned study drug. Only participants who tested positive at Day 1 were included. Analyses were performed based on randomized treatment assignment. Fewer than 5 participants per treatment arm tested positive for Norovirus GI at baseline thus no GI specific statistical analyses were conducted.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nitazoxanide (500 mg)', 'description': 'A single 500 mg tablet of nitazoxanide administered orally twice daily with food for 56 consecutive doses over 28 days.\n\nNitazoxanide: a synthetic antiprotozoal agent, chemically designated as 2-acetyloxy-N-(5-nitro-2-thiazolyl) benzamide. Nitazoxanide will be supplied as 500 mg round, yellow, film-coated tablets.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'A single matching placebo tablet administered orally twice daily with food for 56 consecutive doses over 28 days.\n\nPlacebo: a round, yellow, film-coated tablet with the same inactive ingredients as the nitazoxanide tablet. The placebo tablet will be formulated for the same appearance as nitazoxanide.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COVID-19 Pandemic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nitazoxanide (500 mg)', 'description': 'A single 500 mg tablet of nitazoxanide administered orally twice daily with food for 56 consecutive doses over 28 days.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'A single matching placebo tablet administered orally twice daily with food for 56 consecutive doses over 28 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.9', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '55.8', 'spread': '14.0', 'groupId': 'BG001'}, {'value': '57.4', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of symptoms', 'classes': [{'categories': [{'title': 'Acute', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Chronic', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Duration of symptoms in days. Acute duration is defined as fewer than 14 days. Chronic duration is defined as 14 or more days.', 'unitOfMeasure': 'Participants'}, {'title': 'Transplant type', 'classes': [{'categories': [{'title': 'Solid organ', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Hematopoietic Stem Cell Transplant', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-21', 'size': 1495477, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-05T17:09', 'hasProtocol': True}, {'date': '2022-08-01', 'size': 2677814, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-08-05T16:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06-25', 'completionDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2018-01-04', 'resultsFirstSubmitDate': '2022-08-18', 'studyFirstSubmitQcDate': '2018-01-04', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-26', 'studyFirstPostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Initial Clinical Resolution of Norovirus Symptoms', 'timeFrame': '48 hours through Day 180', 'description': "Time (in days) from randomization until the study day when clinical resolution occurred. Clinical resolution was assessed from participant's daily diaries and was defined as cessation of vomiting and no stools classified by the Bristol Stool Chart as diarrhea (Type 6 or 7) for at least 48 hours."}], 'secondaryOutcomes': [{'measure': 'Number of Participants Experiencing Laboratory Adverse Events (AEs)', 'timeFrame': 'Day 1 (baseline) through Day 60', 'description': 'Participants experiencing at least one new laboratory adverse event. Laboratory parameters include White Blood Cell (WBC), Hemoglobin, Platelet Count, Creatinine, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Blood Urea Nitrogen (BUN), and Bilirubin. Laboratory results were considered AEs using the following thresholds : WBC greater than the upper limit of normal (ULN), hemoglobin less than the lower limit of normal (LLN), platelet count less than the LLN; creatinine greater than the ULN; alkaline phosphatase greater than the ULN; ALT greater than the ULN, AST greater than the ULN, BUN greater than or equal to the ULN, and bilirubin greater than the ULN. ULN and LLN values differed by site, sex, and age category.'}, {'measure': 'Change in Viral Titer (Day 1 to Day 180)', 'timeFrame': 'Day 1 (baseline) and Day 180', 'description': 'Change in viral titer defined as the difference between the Day 180 viral titer and the Day 1 viral titer. Participants were analyzed for the viral load test type (Norovirus GII or Norovirus GI) that they tested positive for at baseline (Day 1).'}, {'measure': 'Number of Participants Reporting Hospitalization', 'timeFrame': 'Day 1 (baseline) through Day 60', 'description': 'Hospitalizations included any admission to a hospital for treatment and were not reported as Serious Adverse Events (SAEs).'}, {'measure': 'Number of Participants Reporting Protocol-Specified SAEs', 'timeFrame': 'Day 1 (baseline) through Day 60', 'description': 'Protocol-specified SAEs included any adverse event or suspected adverse reaction which, in the view of the investigator or sponsor, resulted in any of the following: death, life threatening adverse event, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life function, congenital anomaly or birth defect, or an important medical event that may jeopardize the participant and require medical or surgical intervention. Hospitalizations were collected as a secondary outcome measure and were not reported as SAEs.'}, {'measure': 'Number of Participants Experiencing Unsolicited Non-Serious Adverse Events', 'timeFrame': 'Day 1 (baseline) through Day 60', 'description': 'Unsolicited adverse events were defined as any non-serious clinical adverse events that were not collected as clinical outcome measures and resulted in either modification in the administration of study drug or discontinuation of the study drug.'}, {'measure': 'Time to First Negative Viral Load', 'timeFrame': 'Day 1 (baseline) and Day 180', 'description': 'Time (in days) from randomization until the first study day the participant had either a negative result or a result less than the lower limit of quantitation (LLOQ) for the viral load test type (Norovirus GII or Norovirus GI) that they initially tested positive for at baseline. Participants were analyzed for the viral load test type (Norovirus GII or Norovirus GI) that they tested positive for at baseline (Day 1).'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Efficacy', 'Hematopoietic Stem Cell', 'Nitazoxanide', 'Norovirus', 'Prospective, Randomized, Double-Blind Study', 'Safety', 'Solid Organ Transplant Recipients', 'Treatment'], 'conditions': ['Gastroenteritis Norovirus']}, 'referencesModule': {'references': [{'pmid': '37382971', 'type': 'DERIVED', 'citation': 'Shawar S, Concepcion BP. A Gut-Wrenching Infection: Norovirus in a Kidney Transplant Recipient. Clin J Am Soc Nephrol. 2023 Sep 1;18(9):1231-1233. doi: 10.2215/CJN.0000000000000243. Epub 2023 Jun 29. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 2 multi-center, double-blind, placebo-controlled study of the efficacy and safety of nitazoxanide for the treatment of solid organ and hematopoietic stem cell transplant recipients with symptomatic diarrhea due to Norovirus. The study involves a total of 160 Hematopoietic Stem Cell or Solid Organ transplant recipients, equal to or greater than 12 years of age with diagnosis of Norovirus who will be selected and randomly assigned (1:1) to nitazoxanide or placebo group. The study duration is 60 months and subject participation duration is 6 months. Given the safety of prolonged therapy with nitazoxanide, lack of interactions with common post-transplant medications, putative antiviral activity and prolonged duration of viral shedding we are assessing 56 doses of therapy. The longitudinal monitoring phase will provide useful information on the course of host and viral responses in subjects with chronic Norovirus infection with and without treatment. Randomization will be stratified by age group (pediatric (12 through 17 years) vs. adult (greater than or equal to 18 years)), chronicity of Norovirus-associated symptoms (acute (less than 14 days) vs. chronic (greater than or equal to 14 days)) and transplant type (solid organ (SOT)) vs. hematopoietic stem cell transplant (HSCT)). Enrolled subjects will participate in 2 phases of the study: Treatment Phase, which will include dosing with the assigned study agent for 28 days. Longitudinal Monitoring Phase which will include telephone call on Days 35, 53, 113, 173. Primary objective is 1) to assess the clinical efficacy of nitazoxanide for the management of acute and chronic Norovirus in transplant recipients.', 'detailedDescription': 'This is a phase 2 multi-center, double-blind, placebo-controlled study of the efficacy and safety of nitazoxanide for the treatment of solid organ and hematopoietic stem cell transplant recipients with symptomatic diarrhea due to Norovirus. The study involves a total of 160 Hematopoietic Stem Cell or Solid Organ transplant recipients, equal to or greater than 12 years of age with diagnosis of Norovirus who will be selected and randomly assigned (1:1) into two treatment groups: nitazoxanide or placebo. The study duration is approximately 60 months and subject participation duration is approximately 6 months. Given the safety of prolonged therapy with nitazoxanide, lack of interactions with common post-transplant medications, putative antiviral activity and prolonged duration of viral shedding we are assessing 56 doses of therapy. The longitudinal monitoring phase will provide useful information on the course of host and viral responses in subjects with chronic Norovirus infection with and without treatment. Randomization will be stratified by age group (pediatric (12 through 17 years) vs. adult (greater than or equal to 18 years)), chronicity of Norovirus-associated symptoms (acute (less than 14 days) vs. chronic (greater than or equal to 14 days)) and transplant type (solid organ (SOT)) vs. hematopoietic stem cell transplant (HSCT)). Enrolled subjects will participate in 2 phases of the study: Treatment Phase, which will include dosing with the assigned study agent for 28 days. Longitudinal Monitoring Phase which will include telephone call on Days 35, 53, 113, 173. Primary objective is 1) to assess the clinical efficacy of nitazoxanide for the management of acute and chronic Norovirus in transplant recipients. Secondary Objectives are 1) to assess the virologic efficacy of nitazoxanide and 2) to assess the safety of nitazoxanide for the management of acute and chronic Norovirus in transplant recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects should meet all of the following inclusion criteria:\n\n1. Male or female age \\> / = 12 years.\n2. Recipient of a solid organ or hematopoietic stem cell transplant.\n3. Positive test result for Norovirus within 14 days of enrollment that is obtained as part of routine clinical care using a Norovirus testing available to the site.\n4. Active GI symptoms (diarrhea, or vomiting) that, in the opinion of the PI, are secondary to Norovirus. Patients must have active diarrhea, which is defined as at least 3 days of Bristol 6 or 7 stools in the past 2 weeks prior to enrollment per patient report.\n5. Willing and able to provide written informed consent and assent before initiation of any study procedures, consistent with local IRB policy.\n6. Subjects must be of non-childbearing potential or if of childbearing potential, must be using an effective method of birth control or must be abstinent.\n\n * Non-childbearing potential is defined as surgically sterile or postmenopausal for \\> one year.\n * Effective methods of birth control include the use of hormonal or barrier birth control such as implants, injectable contraceptives, combined oral contraceptives, intrauterine devices (IUDs),or condoms with spermicidal agents during study period. Female subjects must be using an effective method of birth control or practice abstinence and must agree to continue such precautions during the study and for 30 days after the Day 28 study visit.\n * A woman is eligible if she is monogamous with a vasectomized male.This subject is considered low risk and not required to use contraception.\n7. Agrees to complete all screening requirements, study visits and procedures.\n\nExclusion Criteria:\n\nSubjects meeting any of the exclusion criteria at baseline will be excluded from study participation:\n\n1. Other identified infectious causes of diarrhea at screening. Alternative diagnosis requiring treatment would be considered a co-infection; if the testing is positive for a pathogen that the PI does not feel is causing the symptoms, they may be included but the PI or his/her designee must document that the positive test is not clinically significant, does not require treatment and is not causing the symptoms making the patient eligible for enrollment.\n2. Any condition that would, in opinion of the Site Investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.\n3. Subjects receiving oral or intravenous immunoglobulin therapy concurrently or in the 14 days prior to enrollment.\n4. Nitazoxanide use for any illness in the previous 30 days prior to randomization.\n5. Have received experimental products within 30 days prior to the study entry or plan to receive experimental products at any time during the study\n6. Known sensitivity to nitazoxanide or any of the excipients comprising the nitazoxanide tablets.\n7. Subjects unable to swallow oral medications.\n8. Subjects with ostomy.\n9. Women who are pregnant or lactating or have a positive urine pregnancy test at screening/enrollment/Day 1.'}, 'identificationModule': {'nctId': 'NCT03395405', 'briefTitle': 'NNITS-Nitazoxanide for Norovirus in Transplant Patients Study', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Phase 2 Multi-Center, Prospective, Randomized, Double-Blind Study to Assess the Clinical and Antiviral Efficacy and Safety of Nitazoxanide for the Treatment of Norovirus in Hematopoietic Stem Cell and Solid Organ Transplant Recipients', 'orgStudyIdInfo': {'id': '16-0092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitazoxanide Arm', 'description': '500 mg (one tablet) nitazoxanide by mouth twice daily with food for 56 consecutive doses. N=80', 'interventionNames': ['Drug: Nitazoxanide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'Placebo (one tablet) by mouth twice daily with food for 56 consecutive doses. N=80', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Nitazoxanide', 'type': 'DRUG', 'description': 'One 500 mg tablet twice daily with food for 56 consecutive doses', 'armGroupLabels': ['Nitazoxanide Arm']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'One tablet twice daily with food for 56 consecutive doses', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611-2927', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University - Comprehensive Transplant Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160-8500', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center - Infectious Diseases', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21287-0005', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital - Medicine - Infectious Diseases', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109-2029', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan School of Public Health - Epidemiology', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan - Infectious Disease Clinic at Taubman Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '68198-5400', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center - Infectious Diseases', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '45229-3039', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center Vaccine Research Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '15213-3403', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh - Medicine - Infectious Diseases', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15224-1529', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh of UPMC - Pediatric Infectious Diseases", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75390-8884', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center - Internal Medicine Subspecialties Clinic', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98109-4433', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center - Vaccine and Infectious Diseases', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195-7110', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington - Medicine', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}