Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-09 @ 4:43 AM
Study NCT ID:
NCT03035305
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2017-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Mali
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C001205', 'term': 'fanasil, pyrimethamine drug combination'}, {'id': 'D000655', 'term': 'Amodiaquine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36717}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-25', 'studyFirstSubmitDate': '2017-01-17', 'studyFirstSubmitQcDate': '2017-01-25', 'lastUpdatePostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmed malaria case', 'timeFrame': 'From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks', 'description': 'Malaria case is confirmed by a positive malaria rapid diagnostic test. This outcome will be defined as the occurrence of at least one confirmed malaria case from the 2nd through the 4th round of SMC distribution.'}], 'secondaryOutcomes': [{'measure': 'Fever case', 'timeFrame': 'From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks', 'description': 'Fever case is defined by an axillary temperature greater than 37.5⁰C measured by electronic thermometer or notion fever within 48 hours. This outcome will be defined as the occurrence of at least one fever case from the 2nd through the 4th round of SMC distribution.'}, {'measure': 'Global acute malnutrition case', 'timeFrame': 'From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks', 'description': 'Global acute malnutrition is defined by MUAC \\<125mm (orange or red color MUAC) and/or bilateral edema. This outcome will be defined as the occurrence of at least one global acute malnutrition case from the 2nd through the 4th round of SMC distribution.'}, {'measure': 'Moderate acute malnutrition case', 'timeFrame': 'From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks', 'description': 'Moderate acute malnutrition is defined by MUAC between 115-124mm (orange color MUAC). This outcome will be defined as the occurrence of at least one moderate acute malnutrition case from the 2nd through the 4th round of SMC distribution.'}, {'measure': 'Severe acute malnutrition case', 'timeFrame': 'From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks', 'description': 'Severe acute malnutrition is defined by MUAC \\<115mm (red color MUAC) and/or bilateral edema. This outcome will be defined as the occurrence of at least one severe acute malnutrition case from the 2nd through the 4th round of SMC distribution.'}, {'measure': 'Medical referral case', 'timeFrame': 'From the 2nd round of SMC distribution (4 weeks after the date of inclusion) to the 4th round of SMC distribution (12 weeks after the date of inclusion), assessed up to 8 weeks', 'description': 'This outcome will be defined as the occurrence of at least one illness of sufficient severity to warrant referral to the nearest medical structure for evaluation from the 2nd through the 4th round of SMC distribution.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Seasonal malaria chemoprevention', 'Lipid-based nutrient supplement', 'Children', 'Mali'], 'conditions': ['Malaria']}, 'descriptionModule': {'briefSummary': 'SMC LNS Mali is a interventional matched-pair clustered cohort carried out between August and November 2017 in 18 health areas in Kolokani Circle, Koulikoro region, Mali.\n\nThe objective of this study is to determine whether the association SMC and LNS reduces the number of confirmed malaria cases among children 6-59 months during the monthly SMC distribution sessions.', 'detailedDescription': 'Main objective:\n\nTo compare confirmed cases of malaria among children aged 6-59 months between the group receiving SMC combined with LNS (intervention group) and the group receiving only SMC (control group) during the monthly SMC distribution sessions (4 rounds)\n\nSecondary objectives:\n\nTo compare among children aged 6-59 months between two groups\n\n* Fever cases\n* Acute malnutrition cases (global, moderate and severe)\n* Medical referral cases and their reasons\n\nStudy site:\n\nThe study is conducted in 18 health areas in Kolokani Circle, Koulikoro region, Mali. Each group (intervention and control groups) is composed of 9 health areas.\n\nNumber of participants:\n\nBetween 17500 and 22000 in each group (estimation)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Being between 6 and 59 months old\n* Resident in the study area\n* Signed informed consent of the mother or the child's guardian\n\nExclusion Criteria:\n\n* Children allergic to milk, peanuts, sulfadoxine-pyrimethamine or amodiaquine"}, 'identificationModule': {'nctId': 'NCT03035305', 'briefTitle': 'Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Mali', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for International Medical Action'}, 'officialTitle': 'Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Kolokani Circle, Koulikoro Region, Mali, August-November 2016: Interventional Matched-pair Clustered Cohort', 'orgStudyIdInfo': {'id': 'SMC LNS Mali'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SMC and LNS (intervention group)', 'description': 'Children included in the 9 health areas of the intervention group receiving both lipid-based nutrient supplement and seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine', 'interventionNames': ['Dietary Supplement: Lipid-based Nutrient Supplement (LNS)', 'Drug: Seasonal malaria chemoprevention']}, {'type': 'OTHER', 'label': 'SMC only (control group)', 'description': 'Children included in the 9 health areas of the control group receiving seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine', 'interventionNames': ['Drug: Seasonal malaria chemoprevention']}], 'interventions': [{'name': 'Lipid-based Nutrient Supplement (LNS)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'For each round of SMC distribution (total of 4 rounds):\n\n* For children aged 6-11 months: 15 sachets/month or 50g every two days for 4 weeks\n* For children aged 12-59 months: 21 sachets/month or 50g per day for 3 weeks', 'armGroupLabels': ['SMC and LNS (intervention group)']}, {'name': 'Seasonal malaria chemoprevention', 'type': 'DRUG', 'otherNames': ['Sulfadoxine-pyrimethamine plus amodiaquine'], 'description': 'For each round of SMC distribution (total of 4 rounds):\n\n* For children aged 6-11 months: sulfadoxine 250mg/pyrimethamine 12.5mg and amodiaquine 75mg\n* For children aged 12-59 months: sulfadoxine 500mg/pyrimethamine 25mg and amodiaquine 150mg\n\nD1 : 1 tablet sulfadoxine-pyrimethamine + 1 tablet amodiaquine D2 : 1 tablet amodiaquine D3 : 1 tablet amodiaquine', 'armGroupLabels': ['SMC and LNS (intervention group)', 'SMC only (control group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kolokani Circle', 'state': 'Koulikoro', 'country': 'Mali', 'facility': 'Amcp/Alima'}], 'overallOfficials': [{'name': 'Susan Shepherd, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Alliance for International Medical Action (ALIMA)'}, {'name': 'Renaud Becquet, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inserm U1219 Bordeaux Population Health Center, University of Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for International Medical Action', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'Alliance médicale contre le paludisme, Mali', 'class': 'UNKNOWN'}, {'name': 'Programme national de lutte contre le paludisme, Mali', 'class': 'UNKNOWN'}, {'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}, {'name': 'European Commission', 'class': 'OTHER'}, {'name': 'Ministry of health, Mali', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}