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Efficacy of Two Dual Active Ingredient Long Lasting Insecticidal Nets for Control of Malaria Transmitted by Pyrethroid Resistant Vectors in Benin (NNP)

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ClinicalTrials.gov Identifier: NCT03931473
Recruitment Status : Not yet recruiting
First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborators:
Centre de Recherche Entomologique de Cotonou
UNITAID
Innovative Vector Control Consortium
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:

The massive scale-up of Long Lasting Insecticidal Nets (LLIN) has led to a major reduction in malaria burden (up to 50%) in many sub-Saharan African countries. This progress is threatened by the wide scale selection of insecticide resistant malaria vectors. New types of LLIN combining a mixture of two insecticides have been developed to control resistant mosquitoes.

The efficacy of two bi-treated LLIN are compared to a standard LLIN in a three-arm, single blinded, cluster-randomized trial in Cove, Benin. The arms are; 1/ Royal Guard, a net combining pyriproxyfen (PPF), which is known to disrupt female reproduction and fertility of eggs, and the pyrethroid alpha-cypermethrin, 2/Interceptor G2, LLIN incorporating a mixture of two adulticides with different modes of action; chlorfenapyr and a pyrethroid (alpha-cypermethrin), and 3/ The control arm: Interceptor, a standard LLIN treated with alpha-cypermethrin.

The primary outcome of the trial will be malaria case incidence in children aged 6 months to 10 years.


Condition or disease Intervention/treatment Phase
Malaria Anemia Other: Bed nets Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Two Dual Active Ingredient Long Lasting Insecticidal Nets for Control of Malaria Transmitted by Pyrethroid Resistant Vectors in Benin
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Interceptor G2
Chlorfenapyr/alpha-cypermethrin
Other: Bed nets
Next-generation bed nets combining insecticides with different modes of action or a standard pyrethroid bed net

Experimental: Royal Guard
Pyriproxyfen/alpha-cypermethrin
Other: Bed nets
Next-generation bed nets combining insecticides with different modes of action or a standard pyrethroid bed net

Active Comparator: Interceptor
Alpha-cypermethrin
Other: Bed nets
Next-generation bed nets combining insecticides with different modes of action or a standard pyrethroid bed net




Primary Outcome Measures :
  1. Malaria Case Incidence [ Time Frame: 2 years ]
    Malaria case incidence in children aged 6 months to 10 years measured through bi-monthly/monthly visits


Secondary Outcome Measures :
  1. Malaria Infection prevalence [ Time Frame: 18 months ]
    Malaria infection prevalence measured in cross-sectional surveys 6 months and 18 months post- distribution

  2. Entomological Inoculation Rate [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for cohort:

  • Children aged 6 months to 9 years
  • Resident in study villages
  • Written, informed consent from guardians

Exclusion Criteria:

  • Non-residents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931473


Contacts
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Contact: Jackie Cook, PhD 02079272180 jackie.cook@lshtm.ac.uk

Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Centre de Recherche Entomologique de Cotonou
UNITAID
Innovative Vector Control Consortium
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03931473    
Other Study ID Numbers: NewNetsProject
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases