Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-27 @ 4:07 AM
Study NCT ID:
NCT04666350
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2020-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Investigation Study to Evaluate the Consistency and Reproducibility of Two Consecutive Mosquito Feeding Assays
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011319', 'term': 'Primaquine'}, {'id': 'D000077611', 'term': 'Artemether, Lumefantrine Drug Combination'}], 'ancestors': [{'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077549', 'term': 'Artemether'}, {'id': 'D037621', 'term': 'Artemisinins'}, {'id': 'D017382', 'term': 'Reactive Oxygen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000078102', 'term': 'Lumefantrine'}, {'id': 'D005449', 'term': 'Fluorenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D012717', 'term': 'Sesquiterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cockenhouse@path.org', 'phone': '+1 (202) 716-5849', 'title': 'Chris F Ockenhouse, MD, PhD', 'organization': 'PATH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 days', 'eventGroups': [{'id': 'EG000', 'title': 'Study Volunteers', 'description': 'Participants provided a blood sample on Day 1 for Direct Membrane Feeding Assay (DMFA) testing prior to participating in the Direct Skin Feeding Assay (DSFA). On Day 2 participants underwent the second DMFA and DSFA assay (within 24 hours of the first assays).\n\nUpon completion of Day 2 DSFA participants received one dose of primaquine and Coartem for 3 days, except for two women who had a positive pregnancy test at Day 2 and did not receive primaquine.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 32, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Oocyst Prevalence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Mosquitoes', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '543', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Direct Skin Feeding Assay', 'description': 'Each participant underwent a direct skin feeding assay on Day 1 and Day 2.'}, {'id': 'OG001', 'title': 'Direct Membrane Feeding Assay', 'description': 'Blood samples from each participant were used in a direct membrane feeding assay.'}], 'classes': [{'title': 'Day 1 Feeding Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Mosquitoes', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '543', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '16.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 2 Feeding Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Mosquitoes', 'counts': [{'value': '467', 'groupId': 'OG000'}, {'value': '476', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.711', 'groupIds': ['OG000'], 'paramType': 'Combined Difference in Prevalence', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.025', 'ciLowerLimit': '-0.160', 'ciUpperLimit': '0.109', 'groupDescription': 'Comparison of DSFA Day 2 versus Day 1. For each participant, the difference in oocyte prevalence using DSFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.', 'statisticalMethod': 'Other', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.'}, {'pValue': '0.795', 'groupIds': ['OG001'], 'paramType': 'Combined Difference in Prevalence', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.016', 'ciLowerLimit': '-0.139', 'ciUpperLimit': '0.107', 'groupDescription': 'Comparison of DMFA Day 2 versus Day 1. For each participant, the difference in oocyte prevalence using DMFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.', 'statisticalMethod': 'Other', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.'}], 'paramType': 'MEAN', 'timeFrame': 'Feeding assays were performed on Day 1 and Day 2; Oocyst prevalence in surviving mosquitoes was assessed 9 days after feeding (Days 9 and 10).', 'description': "Participants underwent feeding assays on two days, 24 hours apart (day 1 and Day 2). After feeding, mosquitoes were maintained in locked environmental chambers for 9 days to allow oocyst development.\n\nAn oocyst is a structure that develops on the outer wall of the infected mosquito's stomach that contains developing sporozoites.\n\nNine days after feeding mosquito midguts were dissected, stained with 1% mercurochrome and examined by optical microscopy. The number of oocysts in each midgut were recorded.\n\nOocyst prevalence is defined as the percentage of mosquitoes in a cup with at least one oocyst detected in the mid-gut among the surviving mosquitoes (in the same cup) that underwent the feeding assays.", 'unitOfMeasure': 'percentage of mosquitoes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Mosquitoes', 'denomUnitsSelected': 'Mosquitoes', 'populationDescription': 'Participants with available data; one participant did not have surviving mosquitoes in any of the assays and is not included in the analysis.\n\nThe number of mosquitoes analyzed reflects the number of surviving mosquitoes after 9 days for each feeding assay and time point.'}, {'type': 'SECONDARY', 'title': 'Oocyst Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Mosquitoes', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '543', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Direct Skin Feeding Assay', 'description': 'Each participant underwent a direct skin feeding assay on Day 1 and Day 2.'}, {'id': 'OG001', 'title': 'Direct Membrane Feeding Assay', 'description': 'Blood samples from each participant were used in a direct membrane feeding assay.'}], 'classes': [{'title': 'Day 1 Feeding Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Mosquitoes', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '543', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 2 Feeding Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Mosquitoes', 'counts': [{'value': '467', 'groupId': 'OG000'}, {'value': '476', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000'], 'paramType': 'Relative Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '0.21', 'ciUpperLimit': '0.70', 'pValueComment': 'Difference between days was evaluated using zero inflated Poisson regression models having as outcome the number of oocysts, as offset the number of surviving mosquitoes, and adjusted by subject.', 'groupDescription': 'Comparison of DSFA Day 2 versus Day 1.', 'statisticalMethod': 'Poisson Regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.003', 'groupIds': ['OG001'], 'paramType': 'Relative Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '0.11', 'ciUpperLimit': '0.45', 'pValueComment': 'Difference between days was evaluated using zero inflated Poisson regression models having as outcome the number of oocysts, as offset the number of surviving mosquitoes, and adjusted by subject.', 'groupDescription': 'Comparison of DMFA Day 2 versus Day 1.', 'statisticalMethod': 'Poisson Regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Feeding assays were performed on Day 1 and Day 2; Oocyst density in surviving mosquitos was assessed 9 days after feeding (Days 9 and 10).', 'description': "Participants underwent feeding assays on two days, 24 hours apart (Day 1 and Day 2). After feeding, mosquitoes were maintained in locked environmental chambers for 9 days to allow oocyst development.\n\nAn oocyst is a structure that develops on the outer wall of the infected mosquito's stomach that contains developing sporozoites.\n\nNine days after feeding mosquito midguts were dissected, stained with 1% mercurochrome and examined by optical microscopy. The number of oocysts in each midgut were recorded.\n\nOocyst density is defined as the mean number of oocysts detected in infected mosquitoes that underwent feeding assays on the same participant.", 'unitOfMeasure': 'oocysts / mosquito', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Mosquitoes', 'denomUnitsSelected': 'Mosquitoes', 'populationDescription': 'Participants with available data; one participant did not have surviving mosquitoes in any of the assays and is not included in the analysis.\n\nThe number of mosquitoes analyzed reflects the number of surviving mosquitos after 9 days for each feeding assay and time point.'}, {'type': 'SECONDARY', 'title': 'Sporozoite Prevalence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Mosquitoes', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '383', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Direct Skin Feeding Assay', 'description': 'Each participant underwent a direct skin feeding assay on Day 1 and Day 2.'}, {'id': 'OG001', 'title': 'Direct Membrane Feeding Assay', 'description': 'Blood samples from each participant were used in a direct membrane feeding assay.'}], 'classes': [{'title': 'Day 1 Feeding Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Mosquitoes', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '383', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 2 Feeding Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'units': 'Mosquitoes', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '5.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.750', 'groupIds': ['OG000'], 'paramType': 'Combined Difference in Prevalence', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.023', 'ciLowerLimit': '-0.164', 'ciUpperLimit': '0.118', 'groupDescription': 'Comparison of DSFA Day 2 versus Day 1. For each participant, the difference in sporozoite prevalence using DSFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.', 'statisticalMethod': 'Other', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.'}, {'pValue': '0.681', 'groupIds': ['OG001'], 'paramType': 'Combined Difference in Prevalence', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.031', 'ciLowerLimit': '-0.178', 'ciUpperLimit': '0.117', 'groupDescription': 'Comparison of DMFA Day 2 versus Day 1. For each participant, the difference in sporozoite prevalence using DMFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.', 'statisticalMethod': 'Other', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.'}], 'paramType': 'MEAN', 'timeFrame': 'Feeding assays were performed on Day 1 and Day 2; Sporozoite prevalence in surviving mosquitoes was assessed 14 days after feeding (Days 14 and 15).', 'description': 'Participants underwent feeding assays on two days, 24 hours apart (day 1 and Day 2). After feeding, mosquitoes were maintained in locked environmental chambers for 14 days to allow sporozoite development.\n\nSporozoites are the forms of the plasmodium that are liberated from the oocysts in the mosquito, accumulate in the salivary glands of the mosquito, and are transferred to humans when the mosquito feeds.\n\nFourteen days after feeding, salivary glands were dissected from live mosquitoes submerged in phosphate-buffered saline (PBS) in order to visualize motile sporozoites by microscopy. Sporozoite prevalence was recorded.\n\nSporozoite prevalence is defined as the percentage of mosquitoes in a cup with at least one sporozoite detected in the salivary glands among the mosquitoes (in the same cup) that underwent feeding assays.', 'unitOfMeasure': 'percentage of mosquitoes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Mosquitoes', 'denomUnitsSelected': 'Mosquitoes', 'populationDescription': 'Participants with available data; one participant did not have surviving mosquitoes in any of the assays and is not included in the analysis.\n\nThe number of mosquitoes analyzed reflects the number of surviving mosquitos after 14 days for each feeding assay and time point.'}, {'type': 'SECONDARY', 'title': 'Sporozoite Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Direct Skin Feeding Assay', 'description': 'Each participant underwent a direct skin feeding assay on Day 1 and Day 2.'}, {'id': 'OG001', 'title': 'Direct Membrane Feeding Assay', 'description': 'Blood samples from each participant were used in a direct membrane feeding assay.'}], 'timeFrame': 'Day 1 and Day 2', 'description': 'Sporozoite density is defined as the mean number of sporozoites detected in infected mosquitoes that underwent feeding assays.\n\nDue to limitation on the state of the art, it was not possible to estimate the sporozoite density using the Optical Microscopy technique.', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis of sporozoite density could not be conducted due to technical limitations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Volunteers', 'description': 'Participants provided a blood sample on Day 1 for Direct Membrane Feeding Assay (DMFA) testing prior to participating in the Direct Skin Feeding Assay (DSFA). On Day 2 participants underwent the second DMFA and DSFA assay (within 24 hours of the first assays).\n\nUpon completion of Day 2 DSFA participants received one dose of primaquine and Coartem for 3 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Healthy adults with no malaria symptoms were recruited from the villages in the Kombewa Health and Demographics Surveillance System (HDSS) consisting of half of Kisumu West and all of Seme Sub-Counties of Kisumu County in Kenya.', 'preAssignmentDetails': 'Four hundred participants consented and underwent screening. After informed consent was obtained participants were tested for the presence of mature stage malarial parasites (called gametocytes) in their blood. Forty-two participants met the inclusion criteria and were gametocyte positive and agreed to participate in the mosquito feeding assays.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Volunteers', 'description': 'Participants provided a blood sample on Day 1 for Direct Membrane Feeding Assay (DMFA) testing prior to participating in the Direct Skin Feeding Assay (DSFA). On Day 2 participants underwent the second DMFA and DSFA assay (within 24 hours of the first assays).\n\nUpon completion of Day 2 DSFA participants received one dose of primaquine and Coartem for 3 days.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '33.4', 'spread': '9.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Kenya', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ever had malaria?', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-07', 'size': 3488694, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-21T15:30', 'hasProtocol': True}, {'date': '2022-03-09', 'size': 2608023, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-21T15:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Sera collected will be assayed in membrane feeding assay (risk mitigation) only if gametocyte-positive subject fails to transmit any parasites to mosquitoes in either the DSFA or DMFA performed either on day 1 or day 2. Sera will be destroyed before study close-out.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2020-11-24', 'resultsFirstSubmitDate': '2023-01-16', 'studyFirstSubmitQcDate': '2020-12-11', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-21', 'studyFirstPostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oocyst Prevalence', 'timeFrame': 'Feeding assays were performed on Day 1 and Day 2; Oocyst prevalence in surviving mosquitoes was assessed 9 days after feeding (Days 9 and 10).', 'description': "Participants underwent feeding assays on two days, 24 hours apart (day 1 and Day 2). After feeding, mosquitoes were maintained in locked environmental chambers for 9 days to allow oocyst development.\n\nAn oocyst is a structure that develops on the outer wall of the infected mosquito's stomach that contains developing sporozoites.\n\nNine days after feeding mosquito midguts were dissected, stained with 1% mercurochrome and examined by optical microscopy. The number of oocysts in each midgut were recorded.\n\nOocyst prevalence is defined as the percentage of mosquitoes in a cup with at least one oocyst detected in the mid-gut among the surviving mosquitoes (in the same cup) that underwent the feeding assays."}], 'secondaryOutcomes': [{'measure': 'Oocyst Density', 'timeFrame': 'Feeding assays were performed on Day 1 and Day 2; Oocyst density in surviving mosquitos was assessed 9 days after feeding (Days 9 and 10).', 'description': "Participants underwent feeding assays on two days, 24 hours apart (Day 1 and Day 2). After feeding, mosquitoes were maintained in locked environmental chambers for 9 days to allow oocyst development.\n\nAn oocyst is a structure that develops on the outer wall of the infected mosquito's stomach that contains developing sporozoites.\n\nNine days after feeding mosquito midguts were dissected, stained with 1% mercurochrome and examined by optical microscopy. The number of oocysts in each midgut were recorded.\n\nOocyst density is defined as the mean number of oocysts detected in infected mosquitoes that underwent feeding assays on the same participant."}, {'measure': 'Sporozoite Prevalence', 'timeFrame': 'Feeding assays were performed on Day 1 and Day 2; Sporozoite prevalence in surviving mosquitoes was assessed 14 days after feeding (Days 14 and 15).', 'description': 'Participants underwent feeding assays on two days, 24 hours apart (day 1 and Day 2). After feeding, mosquitoes were maintained in locked environmental chambers for 14 days to allow sporozoite development.\n\nSporozoites are the forms of the plasmodium that are liberated from the oocysts in the mosquito, accumulate in the salivary glands of the mosquito, and are transferred to humans when the mosquito feeds.\n\nFourteen days after feeding, salivary glands were dissected from live mosquitoes submerged in phosphate-buffered saline (PBS) in order to visualize motile sporozoites by microscopy. Sporozoite prevalence was recorded.\n\nSporozoite prevalence is defined as the percentage of mosquitoes in a cup with at least one sporozoite detected in the salivary glands among the mosquitoes (in the same cup) that underwent feeding assays.'}, {'measure': 'Sporozoite Density', 'timeFrame': 'Day 1 and Day 2', 'description': 'Sporozoite density is defined as the mean number of sporozoites detected in infected mosquitoes that underwent feeding assays.\n\nDue to limitation on the state of the art, it was not possible to estimate the sporozoite density using the Optical Microscopy technique.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malaria']}, 'referencesModule': {'references': [{'pmid': '40380146', 'type': 'DERIVED', 'citation': 'Akala HM, Aponte JJ, Achola MA, Juma DW, Opot BH, Maisiba RN, Okoth RO, Juma JA, Mwakio EW, Mwalo MA, Oullo DO, Abuom D, Garges EC, Eyase FL, Tina LO, Copeland NK, Roth A, Mutunga J, Onyango I, Johnson J, Ogutu BR, Sifuna P, Hutter J, Mercer L, Raine M, Moore V, Ivinson K, Wu Y, Andagalu B, Ockenhouse CF. Consistency and reproducibility of independent feedings using blood from two consecutive days at varying Plasmodium falciparum gametocyte densities based on both direct membrane feeding assay and direct skin feeding assay. Malar J. 2025 May 16;24(1):154. doi: 10.1186/s12936-025-05360-3.'}]}, 'descriptionModule': {'briefSummary': 'The proposed trial design has been developed to assess the consistency and reproducibility of two consecutive direct skin feeding assays (DSFA) at 24-hour interval.', 'detailedDescription': 'The proposed trial design has been developed to assess the consistency and reproducibility of two consecutive direct skin feeding assays (DSFA) at 24-hour interval. The results will determine the type of pivotal trial design for a follow-on Phase 2b trial whose objective is to bridge the standard membrane feeding assay (SMFA) to the direct skin feeding assay (DSFA) and direct membrane feeding assay (DMFA) using a monoclonal antibody intervention, TB31F monoclonal antibody (mAb), which interrupts transmission from human to mosquito. The results from this experimental medicine study will inform whether the preferred "Before-After" trial design in which each human volunteer serves as their own internal control can be utilized for a follow-on Phase 2b trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The target sample size for subjects with gametocytemia is approximately 45 individuals. Approximately 180 participants will be screened for gametocyte carriage by PCR to achieve the target sample size. Screening of subjects will continue until the desired sample size of gametocytemic individuals who undergo all study procedures is attained. Adults aged 18 - 55 years will be recruited from the villages in the Kombewa Health and Demographics Surveillance System (HDSS) consisting of half of Kisumu', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed or thumb printed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female aged between 18 years and 55 years inclusive.\n* Resident within the study area\n* In good general health as evidenced by medical history and clinical examination before entering the study Ability to take oral Coartem and low-dose primaquine anti-malarials upon conclusion of day 2 (2nd direct skin feed) and be willing to adhere to the medication regimen\n* For females, she must be of non-childbearing potential or use appropriate measures to prevent pregnancy for 30 days after receiving Coartem and primaquine. Non-childbearing potential means she is surgically sterilized or at least one year post-menopausal. Appropriate measures to prevent pregnancy include abstinence or adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant or Depo-Provera).\n* For males, he must be willing to ensure that he does not get his partner(s) pregnant for at least 3 months after treatment with primaquine. Appropriate measures to prevent pregnancy include abstinence or adequate contraceptive precautions in either the participant or the partner.\n* Positive for P. falciparum gametocytes as measured by polymerase chain reaction (PCR) with cycle threshold (cT) value \\< 31.\n\nExclusion Criteria:\n\nPresence of any signs or symptoms of malaria\n\n* Presence of contraindications to administration of Coartem and primaquine as indicated in the respective drug package inserts\n* History of severe allergic reactions to mosquito bites (other than pruritus and local swelling)\n* Pregnant (i.e. a positive pregnancy test)\n* Current or recent (within the preceding 2 weeks) use of antimalarial treatment\n* Current participation in a malaria vaccine study\n* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.'}, 'identificationModule': {'nctId': 'NCT04666350', 'briefTitle': 'Clinical Investigation Study to Evaluate the Consistency and Reproducibility of Two Consecutive Mosquito Feeding Assays', 'organization': {'class': 'OTHER', 'fullName': 'PATH'}, 'officialTitle': 'Clinical Investigation Study to Evaluate the Consistency and Reproducibility of Two Consecutive Mosquito Feeding Assays in Adults With Varying Plasmodium Falciparum Gametocyte Densities', 'orgStudyIdInfo': {'id': 'CVIA 085 -- Phase 0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Volunteers', 'description': 'Participants provided a blood sample on Day 1 for DMFA testing and then participated in the mosquito feeding assay. On Day 2 participants underwent a second DMFA and DSFA assay (within 24 hours of the first assays).\n\nUpon completion of Day 2 DSFA participants will receive one dose of primaquine and the first dose of a 3-day regiment of artemether/lumefantrine.', 'interventionNames': ['Other: Direct Skin Feeding Assay (DSFA)', 'Drug: Primaquine', 'Drug: Artemether/Lumefantrine']}], 'interventions': [{'name': 'Direct Skin Feeding Assay (DSFA)', 'type': 'OTHER', 'description': "In the direct feeding assay a cup with 60 unfed, sterile insectary-reared Anopheles gambiae mosquitoes will be allowed to feed on a participant's calf or arm for 15 minutes.", 'armGroupLabels': ['Study Volunteers']}, {'name': 'Primaquine', 'type': 'DRUG', 'description': 'Participants will receive one dose of primaquine 26.3 mg tablet on Day 2 after completion of the direct feeding assay.', 'armGroupLabels': ['Study Volunteers']}, {'name': 'Artemether/Lumefantrine', 'type': 'DRUG', 'otherNames': ['Coartem®'], 'description': 'Participants will receive artemether (80 mg) and lumefantrine (480 mg) combination tablets twice a day for 3 days, starting after completion of the direct feeding assay on Day 2.', 'armGroupLabels': ['Study Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kombewa', 'country': 'Kenya', 'facility': 'KEMRI', 'geoPoint': {'lat': -0.10336, 'lon': 34.51791}}], 'overallOfficials': [{'name': 'Ben Andagalu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Drug Resistance Laboratory, KEMRI'}, {'name': 'Hoseah Akala, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Drug Resistance Laboratory, KEMRI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PATH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Walter Reed Army Institute of Research (WRAIR)', 'class': 'FED'}, {'name': 'Kenya Medical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}