Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT05796193
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-15
First Post:
2023-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Net Transition Initiative: Efficacy of Two Next-generation Nets for Control of Malaria in Cote D'Ivoire
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': 'C017160', 'term': 'cypermethrin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1650}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2023-03-21', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'gSG6-P1 IgG seroprevalence using ELISA technique', 'timeFrame': 'baseline', 'description': 'Serological responses to mosquito salivary peptides: Blood spots on filter paper will be utilized to measure the level of antibodies in residents blood as a proxy for exposure to mosquito bites'}, {'measure': 'gSG6-P1 IgG seroprevalence using ELISA technique', 'timeFrame': '12 months post intervention', 'description': 'Serological responses to mosquito salivary peptides: Blood spots on filter paper will be utilized to measure the level of antibodies in residents blood as a proxy for exposure to mosquito bites'}, {'measure': '30 minutes mortality in wild Anopheles post exposure to various concentration insecticide in CDC bottle assay', 'timeFrame': 'Baseline', 'description': 'Phenotypic resistance to alpha-cypermethrin, PBO + alpha-cypermethrin and chlorfenapyr using WHO cylinder and CDC bottle bioassays will be conducted'}, {'measure': '24 hours mortality in wild Anopheles post exposure to various concentration insecticide in CDC bottle assay', 'timeFrame': 'Baseline', 'description': 'Phenotypic resistance to alpha-cypermethrin, PBO + alpha-cypermethrin and chlorfenapyr using WHO cylinder and CDC bottle bioassays will be conducted'}, {'measure': '72 hours mortality in wild Anopheles post exposure to various concentration insecticide in CDC bottle assay', 'timeFrame': 'Baseline', 'description': 'Phenotypic resistance to alpha-cypermethrin, PBO + alpha-cypermethrin and chlorfenapyr using WHO cylinder and CDC bottle bioassays will be conducted'}, {'measure': '30 minutes mortality in wild Anopheles post exposure to various concentration insecticide in CDC bottle assay', 'timeFrame': '12 months post intervention', 'description': 'Phenotypic resistance to alpha-cypermethrin, PBO + alpha-cypermethrin and chlorfenapyr using WHO cylinder and CDC bottle bioassays will be conducted'}, {'measure': '24 hours mortality in wild Anopheles post exposure to various concentration insecticide in CDC bottle assay', 'timeFrame': '12 months post intervention', 'description': 'Phenotypic resistance to alpha-cypermethrin, PBO + alpha-cypermethrin and chlorfenapyr using WHO cylinder and CDC bottle bioassays will be conducted'}, {'measure': '72 hours mortality in wild Anopheles post exposure to various concentration insecticide in CDC bottle assay', 'timeFrame': '12 months post intervention', 'description': 'Phenotypic resistance to alpha-cypermethrin, PBO + alpha-cypermethrin and chlorfenapyr using WHO cylinder and CDC bottle bioassays will be conducted'}, {'measure': 'Relative fold change in expression of metabolic genes', 'timeFrame': 'Baseline', 'description': 'Selection for resistance will be monitored by measuring changes in levels of metabolic enzyme expression between wild population of Anopheles and susceptible reference Anopheles'}, {'measure': 'Relative fold change in expression of metabolic genes', 'timeFrame': '12 months post intervention', 'description': 'Selection for resistance will be monitored by measuring changes in levels of metabolic enzyme expression between wild population of Anopheles and susceptible reference Anopheles'}, {'measure': 'Concentration of PBO, alpha-cypermethrin and Chlorfenapyr in g per kg in mosquito net', 'timeFrame': 'Before net distribution', 'description': 'Concentration of chemical will be assessed by HPLC'}, {'measure': '24 hours and 72 hours mortality in a susceptible colony of Anopheles gambiae after exposure to new pieces of mosquito nets', 'timeFrame': 'Before net distribution', 'description': 'Bio-efficacy testing will be conducted in standard WHO cone bio-assay and/or tunnel test'}, {'measure': '24 hours and 72 hours mortality in a resistant colony of Anopheles gambiae after exposure to new pieces of mosquito nets', 'timeFrame': 'Before net distribution', 'description': 'Bio-efficacy testing will be conducted in standard WHO cone bio-assay and/or tunnel test'}], 'primaryOutcomes': [{'measure': 'malaria case incidence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]', 'timeFrame': 'Over one year follow up', 'description': 'Incidence of malaria cases (fever above 37.5C or history of a fever in the last 48 hours and a positive RDT) in children aged 6 months to 10 years.'}], 'secondaryOutcomes': [{'measure': 'Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]', 'timeFrame': 'Baseline', 'description': 'Malaria infection prevalence (by RDT) in the study population of all ages'}, {'measure': 'Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]', 'timeFrame': '6 months post intervention', 'description': 'Malaria infection prevalence (by RDT) in the study population of all ages'}, {'measure': 'Malaria infection prevalence by malaria rapid diagnostic test HRP2/pLDH [pf/pan]', 'timeFrame': '12 months post intervention', 'description': 'Malaria infection prevalence (by RDT) in the study population of all ages'}, {'measure': 'Vector Density per person per night using human indoor and outdoor landing catches', 'timeFrame': 'Over one year follow up', 'description': 'Indoor and outdoor Anopheles density per night per person'}, {'measure': 'Sporozoite rate in Anopheles detected using Enzyme Linked Immuno-Sorbent Assay (ELISA) circumsporozoite protein technique. landing catches', 'timeFrame': 'Over one year follow up', 'description': 'Proportion of Anopheles with malaria circumsporozoites in salivary gland'}, {'measure': 'Mean number of Plasmodium spp infective malaria vectors collected per person per night', 'timeFrame': 'Over one year follow up', 'description': 'Entomological inoculation rate measure as vector density x sporozoite rate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anopheles density', 'Entomological inoculation rate', 'Malaria case incidence', 'Malaria infection prevalence'], 'conditions': ['Malaria']}, 'referencesModule': {'references': [{'pmid': '38419075', 'type': 'DERIVED', 'citation': "Sih C, Protopopoff N, Koffi AA, Ahoua Alou LP, Dangbenon E, Messenger LA, Kulkarni MA, Zoh MG, Camara S, Assi SB, N'Guessan R, Cook J. Efficacy of chlorfenapyr-pyrethroid and piperonyl butoxide-pyrethroid long-lasting insecticidal nets (LLINs) compared to pyrethroid-only LLINs for malaria control in Cote d'Ivoire: a three group, cluster randomised trial. Trials. 2024 Feb 28;25(1):151. doi: 10.1186/s13063-024-07969-2."}]}, 'descriptionModule': {'briefSummary': "The investigator plan to conduct a three-arm cluster-randomized control trial which compares two next generation of long-lasting Insecticidal Nets (LLINs); Veeralin®LLIN (PBO-py LLIN), Interceptor G2 (chlorfenapyr-py LLIN) to a standard py-LLIN in the department of Tiebissou Southern Bouake city, central Côte d'Ivoire.\n\nThe primary objective of the project is to evaluate the efficacy of chlorfenapyr-pyrethroid and piperonyl-butoxide (PBO) synergist-pyrethroid LLINs on malaria case incidence in children aged 6 months to 10 years compared to standard pyrethroid-only LLINs. The secondary objectives are to evaluate the efficacy of the two intervention LLINs compared to the standard LLIN on a) malaria infection prevalence in the general population (both children and adults), b) vector density and c) entomological inoculation rate (EIR) (as a proxy for malaria transmission). In addition, changes in phenotypic resistance intensity and selection for molecular resistance mechanisms at baseline and 12 months post-LLIN distribution, in sentinel villages in each treatment arm will be investigate.\n\nIt is vital to demonstrate that these next generation LLINs which are becoming the standard of care in Sub Saharan AFRICA, are superior to standard py-LLIN in the most extreme resistance areas as this is likely where alternative interventions will be most needed to keep malaria control on track. The trial will generate the first epidemiological evidence on the efficacy of PBO nets compared to py-LLIN in West Africa.", 'detailedDescription': "Background: The massive scale-up of long-lasting insecticidal nets (LLIN) has led to a major reduction in malaria burden in many sub-Saharan African (SSA) countries. This progress is threatened by the wide scale selection of insecticide resistant malaria vectors.\n\nStudy site: The study will be conducted in the department of Tiebissou (Gbeke Region in Lac district) Southern Bouake city, central Côte d'Ivoire. The Lac district is characterized by intense indoor malaria transmission with a prevalence of malaria reaching 51.3% in 2021 in children of under 5 years of age and extremely high pyrethroid resistance intensity in the main malaria vectors Anopheles gambiae s.s. and An. coluzzii.\n\nStudy design: Three-arm superiority, single blinded, cluster-randomised trial with village as the unit of randomisation. The arms consist of; 1/ Veeralin LLIN, a net combining the synergist PBO and the pyrethroid alpha-cypermethrin, 2/Interceptor G2, a mixture LLIN incorporating two adulticides with different modes of action; chlorfenapyr and a pyrethroid (alpha-cypermethrin), and 3/ the control arm: MAGNet LLIN, an alpha-cypermethrin-only LLIN.\n\nActivities/Sample size:\n\nA total of 33 villages (1 village = 1 cluster) with an average of 200 households will be identified and mapped. Nets will be distributed at a central point following national guidelines with 1 net for every 2 people.\n\nTo compare incidence of malaria cases between each intervention study arm and the control arm, a cohort of 50 children (45 + 5 to account for loss to follow up) will be recruited per cluster in 33 clusters for 12 months follow up to be able to detect a 35% relative reduction in malaria cases per child per year (rate ratio 0.65) between the intervention and the reference arms, assuming transmission in the control arm is 1.2 malaria cases per year with a coefficient of variation of 0.29 between clusters. The children will be visited twice a month during the transmission season (April to November) and once a month during the dry season.\n\nMalaria infection prevalence cross-sectional surveys will be conducted, at baseline, 6 and 12 months after LLIN distribution. 50 people of all ages will be randomly selected from each of the 33 clusters (11 clusters per arm x 3 arms) and tested for malaria using RDT. The study will have 80% power to detect a relative 35% lower prevalence (prevalence ratio 0.65 in each intervention arm (VEERALLIN or Interceptor G2) relative to standard LLIN, assuming a prevalence of 50% in the control arm and a coefficient of variation of 0.3.\n\nVector density over 12 months will be followed using Human Landing Collection (HLC) indoor and outdoor with collection in 6 households in every cluster every 2 months. Assuming a mean mosquito density of 28 in the control arm, and a 60% reduction in mosquitoes in the intervention arms, with a coefficient of variation of 0.55 between clusters, this will give 80% power to detect differences at each timepoint.\n\nInsecticide resistance intensity will be monitored at baseline and post intervention using adapted CDC bottle assays. The mechanism involved in resistance to pyrethroid and chlorfenapyr will be screened."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For adults: willing to participate and provide consent\n* For children: Having a parents/adult caregiver willing to provide written consent for the household and clinical survey and assent for children over 10\n* Residing in the village over the last 3 months\n* Be aged 6 months to 9 years old at time of recruitment (for the cohort)\n\nExclusion Criteria:\n\n* Children who are expected to be non-resident over the period of study will be excluded (for the cohort)\n* Dwelling not found or vacant during the survey (for prevalence and entomological surveys)\n* No adult caregiver capable to give informed consent (All activities)\n* Habitants/selected participants severely ill'}, 'identificationModule': {'nctId': 'NCT05796193', 'briefTitle': "Net Transition Initiative: Efficacy of Two Next-generation Nets for Control of Malaria in Cote D'Ivoire", 'organization': {'class': 'OTHER', 'fullName': 'London School of Hygiene and Tropical Medicine'}, 'officialTitle': "Net Transition Initiative: Efficacy of Two Next-generation Nets for Control of Malaria in Cote D'Ivoire", 'orgStudyIdInfo': {'id': '28390'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Py-PBO LLIN', 'description': 'Veeralin is a long-lasting net of 130 deniers containing the pyrethroid insecticide alpha-cypermethrin 6.0 g/kg (216 mg/m2) and the synergist piperonyl butoxide (PBO) 2.2 g/kg (79.2 mg/m2) and manufactured by VKA polymers.', 'interventionNames': ['Other: Alpha-cypermethrin and PBO LLIN']}, {'type': 'EXPERIMENTAL', 'label': 'Py-CFP LLIN', 'description': 'Interceptor® G2 is a long-lasting dual insecticide treated nets of 100 deniers combining Alpha-cypermethrin 2.4 g/kg (100 mg/m2) and Chlorfenapyr 4.8 g/kg (200 mg/m2) manufactured by BASF', 'interventionNames': ['Other: Alpha-cypermethrin and Clorfenapyr LLIN']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Py LLIN', 'description': 'MAGNet® is a long-lasting net of 150 deniers containing the pyrethroid insecticide alpha-cypermethrin 5.8 g/kg (261 mg/m2) only and manufactured by VKA polymers.', 'interventionNames': ['Other: Alpha-cypermethrin only LLIN']}], 'interventions': [{'name': 'Alpha-cypermethrin and PBO LLIN', 'type': 'OTHER', 'description': 'Veeralin Long lasting insecticidal net with Alpha-cypermethrin Pyrethroid insecticide and PBO', 'armGroupLabels': ['Py-PBO LLIN']}, {'name': 'Alpha-cypermethrin and Clorfenapyr LLIN', 'type': 'OTHER', 'description': 'Interceptor G2 dual active ingredient LLIN with with Alpha-cypermethrin Pyrethroid insecticide and Clorfenapyr', 'armGroupLabels': ['Py-CFP LLIN']}, {'name': 'Alpha-cypermethrin only LLIN', 'type': 'OTHER', 'description': 'reference: standard pyrethroid LLIN', 'armGroupLabels': ['Py LLIN']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bouaké', 'country': 'Côte d’Ivoire', 'facility': 'Institut Pierre Richet', 'geoPoint': {'lat': 7.69385, 'lon': -5.03031}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut Pierre Richet', 'class': 'OTHER_GOV'}, {'name': 'University of Ottawa', 'class': 'OTHER'}, {'name': 'University of Nevada, Las Vegas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}