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

NCT03931473 | Completed DMC

• 1 other identifier: NewNetsProject
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria; Anemia

Keywords

Long Lasting Insecticidal Net, Chlorfenapyr, Pyriproxyfen, Pyrethroid, Randomised Controlled Trial, Benin, Vector Control, Malaria

Outcome Measures

Primary Outcomes (1)

• Malaria Case Incidence

  Malaria case incidence in children aged 6 months to 10 years measured through bi-monthly/monthly visits

  2 years

Secondary Outcomes (2)

• Malaria Infection prevalence

  18 months

• Entomological Inoculation Rate

  2 years

Study Arms (3)

Interceptor G2

EXPERIMENTAL

Chlorfenapyr/alpha-cypermethrin

Other: Bed nets

Royal Guard

EXPERIMENTAL

Pyriproxyfen/alpha-cypermethrin

Other: Bed nets

Interceptor

ACTIVE COMPARATOR

Alpha-cypermethrin

Other: Bed nets

Interventions

Bed nets OTHER

Next-generation bed nets combining insecticides with different modes of action or a standard pyrethroid bed net

Interceptor; Interceptor G2; Royal Guard

Eligibility Criteria

• Age: 6 Months - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Non-residents

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Centre de Recherche Entomologique de Cotonou: collaborator
• UNITAID: collaborator
• Innovative Vector Control Consortium: collaborator
• Global Fund: collaborator

Study Sites (1)

Manfred Accrombessi

Cové, Benin

Location

Related Publications (7)

• Accrombessi M, Cook J, Ngufor C, Sovi A, Dangbenon E, Yovogan B, Akpovi H, Hounto A, Thickstun C, Padonou GG, Tokponnon F, Messenger LA, Kleinschmidt I, Rowland M, Akogbeto MC, Protopopoff N. Assessing the efficacy of two dual-active ingredients long-lasting insecticidal nets for the control of malaria transmitted by pyrethroid-resistant vectors in Benin: study protocol for a three-arm, single-blinded, parallel, cluster-randomized controlled trial. BMC Infect Dis. 2021 Feb 19;21(1):194. doi: 10.1186/s12879-021-05879-1.

  PMID: 33607958 BACKGROUND

• Yovogan B, Sovi A, Padonou GG, Adoha CJ, Akinro B, Chitou S, Accrombessi M, Dangbenon E, Akpovi H, Messenger LA, Osse R, Hounto AO, Cook J, Kleinschmidt I, Ngufor C, Rowland M, Protopopoff N, Akogbeto MC. Pre-intervention characteristics of the mosquito species in Benin in preparation for a randomized controlled trial assessing the efficacy of dual active-ingredient long-lasting insecticidal nets for controlling insecticide-resistant malaria vectors. PLoS One. 2021 May 20;16(5):e0251742. doi: 10.1371/journal.pone.0251742. eCollection 2021.

  PMID: 34014982 BACKGROUND

• Accrombessi M, Cook J, Dangbenon E, Yovogan B, Akpovi H, Sovi A, Adoha C, Assongba L, Sidick A, Akinro B, Osse R, Tokponnon F, Aikpon R, Ogouyemi-Hounto A, Padonou GG, Kleinschmidt I, Messenger LA, Rowland M, Ngufor C, Protopopoff N, Akogbeto MC. Efficacy of pyriproxyfen-pyrethroid long-lasting insecticidal nets (LLINs) and chlorfenapyr-pyrethroid LLINs compared with pyrethroid-only LLINs for malaria control in Benin: a cluster-randomised, superiority trial. Lancet. 2023 Feb 11;401(10375):435-446. doi: 10.1016/S0140-6736(22)02319-4. Epub 2023 Jan 24.

  PMID: 36706778 RESULT

• Sovi A, Yovogan B, Adoha CJ, Akinro B, Accrombessi M, Dangbenon E, Assongba L, Salako AS, Padonou GG, Messenger LA, Ngufor C, Cook J, Protopopoff N, Akogbeto MC. Efficacy of pyrethroid-pyriproxyfen and pyrethroid-chlorfenapyr nets on entomological indicators of malaria transmission: third year of a randomised controlled trial in Benin. Sci Rep. 2024 Jun 5;14(1):12958. doi: 10.1038/s41598-024-63883-2.

  PMID: 38839981 RESULT

• Ngufor C, Fagbohoun J, Fongnikin A, Ahoga J, Syme T, Ahogni I, Accrombessi M, Protopopoff N, Cook J, Dangbenon E, Sovi A, Baes M, Pigeon O, Todjinou D, Govoetchan R, Padonou GG, Akogbeto M. The attrition, physical and insecticidal durability of two dual active ingredient nets (Interceptor(R) G2 and Royal Guard(R)) in Benin, West Africa: results from a durability study embedded in a cluster randomised controlled trial. Parasit Vectors. 2024 Oct 7;17(1):420. doi: 10.1186/s13071-024-06504-1.

  PMID: 39375740 RESULT

• Accrombessi M, Cook J, Dangbenon E, Sovi A, Yovogan B, Assongba L, Adoha CJ, Akinro B, Affoukou C, Padonou GG, Kleinschmidt I, Messenger LA, Rowland M, Ngufor C, Akogbeto MC, Protopopoff N. Effectiveness of pyriproxyfen-pyrethroid and chlorfenapyr-pyrethroid long-lasting insecticidal nets (LLINs) compared with pyrethroid-only LLINs for malaria control in the third year post-distribution: a secondary analysis of a cluster-randomised controlled trial in Benin. Lancet Infect Dis. 2024 Jun;24(6):619-628. doi: 10.1016/S1473-3099(24)00002-1. Epub 2024 Feb 21.

  PMID: 38401551 RESULT

• Sovi A, Adoha CJ, Yovogan B, Cross CL, Dee DP, Konkon AK, Sidick A, Accrombessi M, Ahouandjinou MJ, Osse R, Dangbenon E, Towakinou L, Agbangla C, Padonou GG, Churcher TS, Ngufor C, Cook J, Protopopoff N, Akogbeto MC, Messenger LA. The effect of next-generation, dual-active-ingredient, long-lasting insecticidal net deployment on insecticide resistance in malaria vectors in Benin: results of a 3-year, three-arm, cluster-randomised, controlled trial. Lancet Planet Health. 2024 Nov;8(11):e894-e905. doi: 10.1016/S2542-5196(24)00232-8.

  PMID: 39515347 DERIVED

MeSH Terms

Conditions

Malaria; Anemia

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Martin C Akogbéto, PhD

  Centre de Recherche Entomologique de Cotonou

  PRINCIPAL INVESTIGATOR

• Natacha Protopopoff, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 30, 2019
• Study Start: June 1, 2020
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)