Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Attraente prova mirata di esche di zucchero in Mali

3 novembre 2026 aggiornato da: University Clinical Research Center, Mali

Attraente prova di fase III dell'esca mirata allo zucchero in Mali

Globally, the female mosquitoes to be effective at transmitting malaria parasites, must have a number of characteristics including: abundance, longevity (individual mosquitoes must survive long enough after feeding on infected blood to allow the parasite time to develop and travel to the mosquito's salivary glands), capacity (each female mosquito must be both susceptible to infection with Plasmodium and able to carry enough malaria parasites in the salivary glands), contact with humans (frequently feed on humans).

Vectors in SSA are often anthropophagic and anthropophilic, and exhibit indoor biting and indoor resting behavior. Highly effective interventions against vectors have been developed and implemented at scale (e.g., indoor Residual Spraying of Insecticides [IRS] and Long Lasting Insecticide-treated Nets [LLINs]). While these interventions have contributed importantly to the reduction of malaria transmission and disease (68% and 11% respectively), none of them target outdoor-biting g and outdoor-resting mosquitoes. Given the increase in resistance to current generation of insecticides and the behavioral plasticity of vectors that results in continued malaria transmission despite high coverage of LLINs or IRS, there is a need for interventions that can supplement and complement LLINs and IRS by killing mosquitoes outside houses using other biologic mechanisms (e.g., targeting sugar feeding behavior). Finally, insecticides with novel modes of action that may be capable of restoring sensitivity to pyrethroids by killing both pyrethroid resistant and sensitive mosquitoes are required. Attractive Target Sugar Baits (ATSBs) that kill mosquitoes through the ingestion of the toxicant dinotefuran (and possibly by other ingestion toxicants that are effective when ingested) potentially fill the need for outdoor interventions with novel killing effects. This study aims to establish the efficacy and contribution of the ATSBs for controlling malaria transmission where An. gambiae s.l. and An. Funestus are the major vectors for malaria.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The current dominant malaria vector control tools remain critically important and have saved many lives. Yet, they are not well-suited for malaria vectors that avoid contact with indoor insecticides by predominantly biting outdoors, by frequently biting animals, and by resting outdoors or remaining within houses only briefly when they do enter. These behaviors allow residual populations of vector mosquitoes to survive, expand, and to increasingly contribute to malaria transmission, despite high coverage. These vectors can sustain endemic transmission even if they rarely bite humans. An. arabiensis is a particularly important source of persistent residual transmission despite Long Lasting Insecticide-treated Net (LLIN) scale-up; this mosquito prefers to feed on animals, and, often bites and rests outside, and has limited indoor exposure. There is need for new vector control tools to target residual outdoor transmission.

In addition to the biological need for female Anopheles species to take a blood meal to obtain protein necessary for egg production, all Anopheles must feed regularly and frequently on liquid and carbohydrates (sugars) to survive. Common sources of liquid and sugar meals include plant tissue and floral nectar. Mosquitoes are guided to sugar sources by chemical attractants. The Attractive Target Sugar Baits (ATSBs) is designed specifically to attract the mosquito with a source of liquid and sugar and include an ingestion toxicant to then kill the mosquito. Using sugar sources to attract mosquitoes to an ingestion toxicant is a relatively simple and inexpensive, strategy that has been shown to be highly efficacious for mosquito control in a limited number of trials. Limited data suggest efficacy, even in sugar-rich environments, due to the high frequency of sugar feeding.

Early studies examined the effect of spraying ingestion toxicants on attractive flowers to use their scent as bait. While these flowers effectively attract the target mosquitoes, the impact on non-target insects, especially pollinators, can be devastating. Furthermore, this approach is not suitable where there is a lack of flowering vegetation. Subsequent studies evaluated locally available plants and fruits as attractants. While such attractants can be sprayed onto non-flowering green vegetation, further studies evaluated products (bait stations) that could be used across a wide variety of settings including indoors and in areas without suitable vegetation.

Westham Compagny recently developed a bait station that contains a plant-based mosquito attractant, sugar as a feeding stimulant, and an active ingredient (the neonicotinoid, dinotefuran) to kill the foraging vectors. The bait station has a protective membrane that covers and protects the bait from rain and dust, but that allows mosquitoes to feed through it. The Westham ATSB can remain effective in the field for at least six months and has a shelf life of greater than three years with no specific requirements for storage. This Attractive Target Sugar Bait (ATSB) is now being produced at an industrial scale, uses simple and widely available ingredients, and is environmentally friendly. The bait station was designed to have the lowest practicable material content with a high proportion of the mass being fully biodegradable. The protective membrane allows mosquitoes to feed, but it serves as a barrier to pollinators. Field studies to-date have also shown that the ATSB has a minimal impact on non-target organisms. This includes evidence specifically for the toxicant that will be used, dinotefuran. Initial environmental assessment and subsequent field trials in Mali have demonstrated that when deployed within the ATSB, the toxicant does not pose safety risks to non-target organisms, including pollinators and humans.

ATSBs may be a particularly important vector control tool in the context of insecticide resistance. Insecticide resistance for the six insecticide classes currently used in LLINs and IRS threatens malaria prevention efforts. Resistance to pyrethroids (used in LLINs and IRS) is commonly reported. If pyrethroids lose most of their efficacy, more than 55% of the benefits of vector control could be lost. ATSBs can help mitigate insecticide resistance to these contact insecticides because they can use ingestion toxicants from very different chemical classes. There are many existing ingestion toxicants that may be used in a bait station, which could facilitate resistance prevention strategies, such as rotation or combination approaches.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

6068

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Mali
      • Bamako, Mali, Mali, 5445
        • University Clinical Research Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 5 anni a 14 anni (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion criteria

  • . Household resident of the selected villages
  • Aged 5 to 14 years of age at the time of enrollment
  • All parents or guardians provide consent for their child's participant (5-14 years old)
  • If age 12 - 14 years, the child also provides assent for participation
  • Absence of pregnancy

Exclusion criteria

  • Not resident of any household within the selected villages
  • Children below 5 years old
  • Aged 15 years and older
  • Pregnancy
  • Do not consent or assent (14 years old)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention arm

ATSB+LLINs+Standard Care for Malaria case management

Within the intervention area, a total of four ATSB station will be deployed (external wall). ATSB stations will be monitored by community health workers through weekly visit and all stations will be replaced 6months after deployment.

Nessun intervento: Standard arm or arm 2

LLINs+Standard Care for MalarIA case management

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Malaria incidence per person times
Lasso di tempo: Through study completion (average 2 years

Malaria case incidence (the total number of incident malaria cases detected by RDT divided by the total person-time followed up in cohorts) will be assessed among people aged 5 to < 15 years old

Through study completion (average 2 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of malaria per person times using molecular analysis tools
Lasso di tempo: Through study completion (average 2 years

PCR will be use to assess Incidence of malaria infection among cohort participants aged 5 to <15 years.

2. Prevalence of malaria infection among a cross sectional sample 3. Incidence rate of passively reported clinical malaria among participants of all ages, defined as the number of malaria confirmed cases (by RDT or microscopy) per 1,000 population per year, 4. Vector age structure: survivorship will be monitored by ovarian dissection to examine ovarian dilatations.

5. Vector densities, Sporozoite rate by CS ELISA, Entomological inoculation rates (EIR), Biting profiles, Vector species composition.

6. Durability of the ATSB stations: 1) the effectiveness of the attractant; and 2) the effective toxicity of the ATSB.

7. Resistance to the ATSB toxicant: susceptibility to the ingestion toxicant (dinotefuran) will be evaluated on an annual basis.

a. Insecticide resistance: Physiological resistance phenotypes, Intensity of resistance, Behavioral resistance

Through study completion (average 2 years

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Community acceptance of ATSBs in intervention area
Lasso di tempo: Through study completion (average 2 years

Removal, alteration of ATSBs stations after deployement will be assessed and reported as acceptance in terms of proportion among intervention sites during the study period (2 years)

Through study completion (average 2 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Direttore dello studio: Seydou Doumbia, PhD, University Clinical Research Center - USTTB - Mali

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 giugno 2022

Completamento primario (Effettivo)

24 gennaio 2024

Completamento dello studio (Effettivo)

7 febbraio 2024

Date di iscrizione allo studio

Primo inviato

1 ottobre 2019

Primo inviato che soddisfa i criteri di controllo qualità

1 novembre 2019

Primo Inserito (Effettivo)

4 novembre 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 6719882

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

The sections below provide details of data management for individual study components. All data will be stored on a secure drive in Mali and shared with PATH. All investigators and the sponsor, Inovated Vector Control Consortium (IVCC), will have access to the data. At London School of Hygien and Tropical Medicine (LSHTM), data will be retained for a minimum of 10 years following project completion as mandated by the LSHTM's policies. Data documentation and the labelled dataset will be deposited in the LSHTM data repository (http://datacompass.lshtm.ac.uk/ ) for long-term curation and preservation at the end of the project.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .