Effectiveness Study of New Generation Bednets in the Context of Conventional Insecticide Resistance in the Democratic Republic of the Congo (Net-PBO)

Université de Lubumbashi

Status and phase: Unknown; Phase 4

Conditions: Insecticide Resistance

Treatments: Drug: Pyrethroids; Drug: synergistic combination of insecticides

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03289663

NET-06-08-76

Details and patient eligibility

About

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.

Enrollment: 1,680 estimated patients

Sex: All

Ages: Under 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,680 participants in 2 patient groups

Control

Active Comparator group

Description:

The arm will receive bednets treated with conventional insecticide (Pyrethroid)

Treatment:

Drug: Pyrethroids

Experimental

Experimental group

Description:

The arm will receive bednets treated with new generation of insecticides (synergistic combination of insecticides)

Treatment:

Drug: synergistic combination of insecticides