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

NCT ID: NCT03289663

Last Updated: 2018-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1680 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-02

Study Completion Date

2019-09-30

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.

Detailed Description

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Conditions

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Insecticide Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster-randomized trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Control

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

Group Type ACTIVE_COMPARATOR

Pyrethroids

Intervention Type DRUG

Conventional insecticide

Experimental

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

Group Type EXPERIMENTAL

synergistic combination of insecticides

Intervention Type DRUG

third generation insecticide -treated bednets

Interventions

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synergistic combination of insecticides

third generation insecticide -treated bednets

Intervention Type DRUG

Pyrethroids

Conventional insecticide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universiteit Antwerpen

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Université de Lubumbashi

OTHER

Sponsor Role lead

Responsible Party

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Gillon Ilombe Kaounga

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hôpital Général de Référence Saint Luc

Kisantu, Bas-Congo Province, Democratic Republic of the Congo

Site Status

Countries

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Democratic Republic of the Congo

References

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Gleave K, Lissenden N, Chaplin M, Choi L, Ranson H. Piperonyl butoxide (PBO) combined with pyrethroids in insecticide-treated nets to prevent malaria in Africa. Cochrane Database Syst Rev. 2021 May 24;5(5):CD012776. doi: 10.1002/14651858.CD012776.pub3.

Reference Type DERIVED
PMID: 34027998 (View on PubMed)

Other Identifiers

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NET-06-08-76

Identifier Type: -

Identifier Source: org_study_id

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