MalariaNNPNCT03931473
Efficacy of Two Dual Active Ingredient Long Lasting Insecticidal Nets for Control of Malaria Transmitted by Pyrethroid Resistant Vectors in Benin
A study testing Bed nets in people with Malaria and Anemia, run by London School of Hygiene and Tropical Medicine at 1 site in Benin.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 9 yearsHealthy volunteers can take part
- What is being tested?
- Bed nets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteBenin
- Study dates
- 1 Jun 2020to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6 months to 9 years
- Resident in study villages
- Written, informed consent from guardians
Who cannot join
- Non-residents
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Background: 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 (SSA) countries. This progress is threatened by the wide scale selection of insecticide resistant malaria vectors.
Study site: The study will be conducted in the districts of Cove, Zagnanado and Ouinhi, a collection of three districts found in the Zou department in Benin. This area consists of 100 villages with approximately 40,000 households and a population size of 191,000.
The aim of this research is to evaluate the efficacy of 2 novel dual active Ingredient (AI) LLINs in a community randomized controlled trial on epidemiology outcomes. The trial will take place over 2 years in an area where malaria vectors are resistant to pyrethroid insecticide in Benin, West Africa. Update- the trial is now continuing for a third year.
The primary objective is to assess the efficacy of next generation LLIN on malaria case incidence in children aged 6 months to 10 years, compared to standard LLINs. The secondary objectives are to evaluate the efficacy of the 2 bi-treated LLIN as compared to standard LLIN on a) malaria infection prevalence in children aged 6 months to 10 years; b) prevalence of moderate and severe anaemia in children under 5 years old and c) entomological inoculation rate (EIR) (as a proxy for malaria transmission). In addition, we will compare potential insecticide resistance selection, between the 3 trial arms and evaluate the impact of the new types of LLIN on other entomological outcomes (species composition, blood feeding, resting/feeding behaviour and sterility (oocyte [egg] development).
Study design: Three-arm superiority, single blinded, cluster-randomized trial with village as the unit of randomisation. The arms consist of; 1/ Royal Guard, a net combining pyriproxyfen (PPF), which is known to disrupt female reproduction and egg fertility, and the pyrethroid alpha-cypermethrin, 2/Interceptor G2, a mixture LLIN incorporating two adulticides with different modes of action; chlorfenapyr and a pyrethroid (alpha-cypermethrin), and 3/ The control arm: Standard LLIN Interceptor is an alpha-cypermethrin only LLIN.
The primary outcome of the trial will be incidence of malaria cases (confirmed by rapid diagnostic test (RDT)) in children aged 6 months to 10 years followed for 24 months. Update: the study is now continuing for a further year.
Secondary outcomes are cross-sectional community prevalence of malaria infection (confirmed by RDT) in the study population at 6- and 18-months post-intervention, prevalence of moderate and severe anaemia in children under 5 years old, entomological inoculation rates (EIR), vector density and insecticide resistance intensity. Update: there will also be a 30 month cross-sectional survey.
Sample size: To compare incidence of malaria cases between study arms, we will recruit a cohort of 25 children per cluster in 60 clusters for 24 months follow up to be able to detect a 30% relative reduction in malaria cases per child per year (rate ratio 0.7) between the intervention and the reference arms. The children will be visited twice a month during the transmission season (April to November) and once a month during the dry season. We will conduct malaria infection prevalence cross-sectional surveys, at 6 and 18 months after LLIN distribution. 40 households will be randomly selected from each of the 60 clusters (20 clusters per arm x 3 arms) and information on education, socio economic status, LLIN ownership and usage recorded during each survey. From these 40 households per cluster we will randomly select 70 individuals. The study will have 80% power to detect a relative 30% lower prevalence (prevalence ratio 0.70 in each intervention arm (Royal Guard or Interceptor G2) relative to standard LLIN. Entomological inoculation rate (EIR) will be measured bi-monthly for 2 years in 8 households per cluster in all the clusters. Update: Follow up for cohort children was suspended during the pandemic meaning the primary outcome only included 21 months of follow up- to counteract this, 30 children were selected in each cluster. The follow up is now continuing up to 36 months- post-distribution. Due to logistics, the entomological data collection took place in 4 houses in each cluster every 3 months.
Frequency and intensity resistance assay with An. gambiae, An. arabiensis and An.funestus will be performed using permethrin, alpha-cypermethrin, pyriproxyfen and chlorfenapyr in 6 clusters (2 clusters per arm). An. gambiae s.l. and An. funestus will be screened for mutations in insecticide target sites (Vgsc) and metabolic resistance following CYp6 genes a small group of P450s that are over expressed in insecticide resistant populations. Changes in frequency of these genes and target site mutation will be followed every year in the three arms.
- Being tested
- Bed nets
- Keywords
- Long Lasting Insecticidal Net, Chlorfenapyr, Pyriproxyfen, Pyrethroid, Randomised Controlled Trial, Benin, Vector Control, Malaria
- Medical subject headings
- Malaria, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bed netsOther
Next-generation bed nets combining insecticides with different modes of action or a standard pyrethroid bed net
| Study group | Role | What they receive |
|---|---|---|
| Interceptor G2 | Experimental | Chlorfenapyr/alpha-cypermethrin Receives: Other: Bed nets |
| Royal Guard | Experimental | Pyriproxyfen/alpha-cypermethrin Receives: Other: Bed nets |
| Interceptor | Active comparator | Alpha-cypermethrin Receives: Other: Bed nets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malaria Case Incidence
Malaria case incidence in children aged 6 months to 10 years measured through bi-monthly/monthly visits
Measured: 2 years
Secondary outcomes (2)
Malaria Infection prevalence
Malaria infection prevalence measured in cross-sectional surveys 6 months and 18 months post- distribution
Measured: 18 months
Entomological Inoculation Rate
EIR measured every quarter during entomological surveys
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start1 Jun 2020
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche Entomologique de Cotonou, UNITAID, Innovative Vector Control Consortium, Global Fund
- Responsible party
- Sponsor
- Investigators
- Martin C Akogbéto, PhD, Principal investigator, Centre de Recherche Entomologique de CotonouNatacha Protopopoff, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931473
- Sponsor's protocol ID
- NewNetsProject
- Acronym
- NNP
- Status last verified
- Oct 2024
- First submitted
- 25 Apr 2019
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33607958Yovogan 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.
PubMed 34014982Accrombessi 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.
PubMed 36706778Sovi 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.
PubMed 38839981Ngufor 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.
PubMed 39375740Accrombessi 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.
PubMed 38401551Sovi 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.
PubMed 39515347
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two Dual Active Ingredient Long Lasting Insecticidal Nets for Control of Malaria Transmitted by Pyrethroid Resistant Vectors in Benin
- ClinicalTrials.gov ID
- NCT03931473
- Acronym / sponsor ID
- NNP / NewNetsProject
- Keywords
- Long Lasting Insecticidal Net, Chlorfenapyr, Pyriproxyfen, Pyrethroid, Randomised Controlled Trial, Benin, Vector Control, Malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Centre de Recherche Entomologique de Cotonou, UNITAID, Innovative Vector Control Consortium, Global Fund
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: 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 (SSA) countries. This progress is threatened by the wide scale selection of insecticide resistant malaria vectors.
Study site: The study will be conducted in the districts of Cove, Zagnanado and Ouinhi, a collection of three districts found in the Zou department in Benin. This area consists of 100 villages with approximately 40,000 households and a population size of 191,000.
The aim of this research is to evaluate the efficacy of 2 novel dual active Ingredient (AI) LLINs in a community randomized controlled trial on epidemiology outcomes. The trial will take place over 2 years in an area where malaria vectors are resistant to pyrethroid insecticide in Benin, West Africa. Update- the trial is now continuing for a third year.
The primary objective is to assess the efficacy of next generation LLIN on malaria case incidence in children aged 6 months to 10 years, compared to standard LLINs. The secondary objectives are to evaluate the efficacy of the 2 bi-treated LLIN as compared to standard LLIN on a) malaria infection prevalence in children aged 6 months to 10 years; b) prevalence of moderate and severe anaemia in children under 5 years old and c) entomological inoculation rate (EIR) (as a proxy for malaria transmission). In addition, we will compare potential insecticide resistance selection, between the 3 trial arms and evaluate the impact of the new types of LLIN on other entomological outcomes (species composition, blood feeding, resting/feeding behaviour and sterility (oocyte [egg] development).
Study design: Three-arm superiority, single blinded, cluster-randomized trial with village as the unit of randomisation. The arms consist of; 1/ Royal Guard, a net combining pyriproxyfen (PPF), which is known to disrupt female reproduction and egg fertility, and the pyrethroid alpha-cypermethrin, 2/Interceptor G2, a mixture LLIN incorporating two adulticides with different modes of action; chlorfenapyr and a pyrethroid (alpha-cypermethrin), and 3/ The control arm: Standard LLIN Interceptor is an alpha-cypermethrin only LLIN.
The primary outcome of the trial will be incidence of malaria cases (confirmed by rapid diagnostic test (RDT)) in children aged 6 months to 10 years followed for 24 months. Update: the study is now continuing for a further year.
Secondary outcomes are cross-sectional community prevalence of malaria infection (confirmed by RDT) in the study population at 6- and 18-months post-intervention, prevalence of moderate and severe anaemia in children under 5 years old, entomological inoculation rates (EIR), vector density and insecticide resistance intensity. Update: there will also be a 30 month cross-sectional survey.
Sample size: To compare incidence of malaria cases between study arms, we will recruit a cohort of 25 children per cluster in 60 clusters for 24 months follow up to be able to detect a 30% relative reduction in malaria cases per child per year (rate ratio 0.7) between the intervention and the reference arms. The children will be visited twice a month during the transmission season (April to November) and once a month during the dry season. We will conduct malaria infection prevalence cross-sectional surveys, at 6 and 18 months after LLIN distribution. 40 households will be randomly selected from each of the 60 clusters (20 clusters per arm x 3 arms) and information on education, socio economic status, LLIN ownership and usage recorded during each survey. From these 40 households per cluster we will randomly select 70 individuals. The study will have 80% power to detect a relative 30% lower prevalence (prevalence ratio 0.70 in each intervention arm (Royal Guard or Interceptor G2) relative to standard LLIN. Entomological inoculation rate (EIR) will be measured bi-monthly for 2 years in 8 households per cluster in all the clusters. Update: Follow up for cohort children was suspended during the pandemic meaning the primary outcome only included 21 months of follow up- to counteract this, 30 children were selected in each cluster. The follow up is now continuing up to 36 months- post-distribution. Due to logistics, the entomological data collection took place in 4 houses in each cluster every 3 months.
Frequency and intensity resistance assay with An. gambiae, An. arabiensis and An.funestus will be performed using permethrin, alpha-cypermethrin, pyriproxyfen and chlorfenapyr in 6 clusters (2 clusters per arm). An. gambiae s.l. and An. funestus will be screened for mutations in insecticide target sites (Vgsc) and metabolic resistance following CYp6 genes a small group of P450s that are over expressed in insecticide resistant populations. Changes in frequency of these genes and target site mutation will be followed every year in the three arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interceptor G2 | Experimental | Other: Bed netsChlorfenapyr/alpha-cypermethrin |
| Royal Guard | Experimental | Other: Bed netsPyriproxyfen/alpha-cypermethrin |
| Interceptor | Active comparator | Other: Bed netsAlpha-cypermethrin |
Who may qualify
- Ages
- 6 months to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6 months to 9 years
- Resident in study villages
- Written, informed consent from guardians
Key exclusion criteria (1 listed)
- Non-residents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bed netsNext-generation bed nets combining insecticides with different modes of action or a standard pyrethroid bed net | Other | Interceptor, Interceptor G2, Royal Guard |
Primary outcome
Malaria Case Incidence
Time frame: 2 years
Malaria case incidence in children aged 6 months to 10 years measured through bi-monthly/monthly visits
2 secondary outcomes
Malaria Infection prevalence
Time frame: 18 months
Entomological Inoculation Rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Background: PubMed 33607958Accrombessi 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.
- Background: PubMed 34014982Yovogan 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.
- Results publication: PubMed 36706778Accrombessi 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.
- Results publication: PubMed 38839981Sovi 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.
- Results publication: PubMed 39375740Ngufor 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.
- Results publication: PubMed 38401551Accrombessi 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.
- Derived from this study: PubMed 39515347Sovi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin C Akogbéto, PhD principal investigator
Centre de Recherche Entomologique de Cotonou
Natacha Protopopoff, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bed nets in people with Malaria and Anemia, run by London School of Hygiene and Tropical Medicine at 1 site in Benin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Benin. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malaria Case Incidence (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03931473, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.