Spatial Repellent Products for the Control of Vector Borne Diseases - Malaria - Kenya (SR-M-KEN)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The primary epidemiological endpoint will be the incidence density of first time malaria infections among human cohorts during the follow-up period as detected by polymerase chain reaction assay (PCR). This measure will inform PE (the reduction of incidence) between intervention and control study arms using the formula: PE =[(Ip - Ia)/Ip]* 100%; based on an expected minimum effect size of 30%. First time infections in these subjects will offer relatively unambiguous evidence of the extent of exposure to infectious mosquito bites. The primary entomological endpoint will be adult densities of vector species via human-landing catch (HLC) from sentinel households from intervention and control arms over the follow-up period.
Secondary epidemiological endpoints will be the incidence density of first time malaria infections among human cohorts during the follow-up period as detected by microscopy and the total number of cases averted (i.e., all Plasmodium spp. infections in cohort subjects). Secondary entomological endpoints include number of sporozoite infected mosquitoes, parity and species-specific effects of the spatial repellent product.
Both epidemiological and entomological endpoints will be utilized to look at the relationship between SR and PE based on product coverage (to include diversion and community effects) and insect behavior. The prospect of SR associated temporal cumulative effects on study endpoints (epidemiological and entomological) over transmission seasons will also be investigated by using the cumulative incidence of infection over the season and applying a survival curve analysis of the cohort data.
Type d'étude
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Kisumu, Kenya
- Kemri-Crc
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Children aged 6-59 months
- glucose-6-phosphate dehydrogenase (G6PD) normal (qualitative screen) in sites where P. vivax or P. ovale known prevalence rates represent major burden) and whose treatment with primaquine is implemented within national guidelines
- Hb > 5mg/dl
- Temperature ≤38.0°C) and no moderate or severe acute illness/infection on the day of inclusion
- Sleeps in cluster >90% of nights during any given month
- No plans for extended travel (<1month) outside of home during study
- Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
- Provision of assent/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative
Exclusion Criteria:
- children < 6 months or > 5 years
- G6PD deficiency (qualitative screen) in sites where P. vivax or P. ovale known prevalence rates represent major burden and whose treatment with primaquine is implemented within national guidelines
- Severe anemia
- Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of inclusion
- Sleeps in cluster <90% of nights during any given month
- Plans for extended travel (>1month) outside of home during study
- Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
- No provision of assent/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Placebo
Placebo Produit répulsif sans ingrédient actif
|
Produit répulsif spatial - Émanateur passif.
Le nom du produit est SHIELD de SCJohnson
Autres noms:
|
|
Comparateur actif: Intervention
Produit répulsif spatial avec ingrédient actif
|
Transfluthrine (Ingrédient actif)
Autres noms:
Spatial Repellent product
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence du paludisme
Délai: 104 semaines
|
Incidence des infections paludéennes parmi les cohortes humaines au cours de la période de suivi, telle que détectée par PCR
|
104 semaines
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Neil Lobo, PhD, University of Notre Dame
- Chercheur principal: Nicole Achee, PhD, University of Notre Dame
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SR-M-KEN
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Paludisme
-
Medicines for Malaria VentureComplétéVolontaires en bonne santé | Malaria Falciparum | Malaria VivaxÉtats-Unis
-
Centers for Disease Control and PreventionNational Institute of Health, PeruComplétéMalaria FalciparumPérou