Effectiveness Study of New Generation Bednets in the Context of Conventional Insecticide Resistance in the Democratic Republic of the Congo

Study Overview
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Brief Summary
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Despite the mass distribution of LLINs (long-lasting insecticidal nets) as a Malaria control strategy, populations are still continuously exposed to a high frequency of malarial inoculation in some countries. The situation can be explained by a swift increase in the resistance of Anopheles to common insecticides. To preserve the gains of insecticides and improve their effectiveness, a new generation of bednets treated with piperonyl butoxide combination insectides have emerged.But more evidence is needed to plead for scale up of their usage. The lack of information relating to the additional impact of that combination on the transmission of Malaria, its relative efficacy in real-life setting and its safety in users are the rationale for more investigation.This will be a randomized controlled study on a dynamic cohort of households with 1680, 0-10 years-old subjects in 30 villages will be recruited to compute the effectiveness of this new tool. The findings will be useful information for decision-making by national malaria control programs, their partners, the international community and the bednet manufacturers with regard to the effectiveness of the new combination of insecticides in real-life context. The results will also enable a better design of the tool in the future and a broader understanding of long-term dynamics for sustainability, as well as identification of some factors with negative impacts on the benefits of the strategy.

Official Title
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Effectiveness Study of Bednets Treated With Synegistic Combination of Insectcides in an Area With Pyrethroid-resistant Vectors in the Democratic Republic of the Congo

Conditions
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Insecticide Resistance

Intervention / Treatment
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* Drug: synergistic combination of insecticides
* Drug: Pyrethroids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : -households where there are one or more children below the age of 10 years; Ability and willingness of the head of the household to participate based on signed informed consent (or fingerprint) and with the assistance of an impartial witness (if the head of the household is illiterate) Exclusion Criteria : refusal of the head of household to participate known allergy to insecticides

Ages Eligible for Study
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Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster-randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>The arm will receive bednets treated with conventional insecticide (Pyrethroid) | Drug: Pyrethroids<br>* Conventional insecticide<br>|
| Experimental: Experimental<br>The arm will receive bednets treated with new generation of insecticides (synergistic combination of insecticides) | Drug: synergistic combination of insecticides<br>* third generation insecticide -treated bednets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of laboratory confirmed clinical cases of Malaria | Microscopy to confirm the diagnosis of Malaria | Participants will be actively followed up for 12 months. And any suspected case of clinical Malaria will immediately lead to microscopy and RDT for confirmation | 
| Sporozoite rate | Sporozoite detection by ELISA to determine infectivity of anopheles | Anopheles mosquitoes will be captured every 3 months during 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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synergistic combination, insecticide resistance, vectors