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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03289663

Acronym

Net-PBO

Enrollment

1680

Registered

2017-09-21

Start date

2017-10-02

Completion date

2019-09-30

Last updated

2018-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insecticide Resistance

Keywords

synergistic combination, insecticide resistance, vectors

Brief summary

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.

Interventions

DRUGsynergistic combination of insecticides

third generation insecticide -treated bednets

DRUGPyrethroids

Conventional insecticide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Masking description

The 2 groups of villages will randomly receive either the bednets treated with conventional insecticide (Pyrethroid) or the synergistic combination of insecticides. None of the groups knows which bednets they receive.

Intervention model description

Cluster-randomized trial

Eligibility

Sex/Gender

ALL

Age

No minimum to 10 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Sporozoite rate	Anopheles mosquitoes will be captured every 3 months during 1 year	Sporozoite detection by ELISA to determine infectivity of anopheles
Incidence rate of laboratory confirmed clinical cases 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	Microscopy to confirm the diagnosis of Malaria

Countries

Democratic Republic of the Congo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026