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MalariaPhase 3REACTNCT03074435

Insecticide Resistance Management in Burkina Faso and Côte D'Ivoire

A Phase 3 study testing Indoor residual sprayings, Larvicide and BCC in people with Malaria, run by Institut de Recherche pour le Developpement at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the benefit to use 1) insecticide residual sprayings, 2) larvicides, 3) Ivermectin for domestic animals and 4) behaviour change communication strategy to complement the universal coverage with LLINs through a cluster randomized trial. Read more about this study

Who is it for?
Ages Up to 21 yearsHealthy volunteers can take part
Conditions the study is for
Malaria
What is being tested?
Indoor residual sprayings, Larvicide and BCC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15,776 participants
Where
2 sitesin 2 countries
Study dates
Jul 2016to Aug 2018
Phase
Phase 3
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 Up to 21 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

For Cross-sectional surveys only, maximum age for participating in the study was 21 y/o in Côte d Ivoire and 18 y/o in Burkina Faso.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Burkina Faso1 site

  • Institut de Recherche en Sciences de la Santé

    Bobo-Dioulasso

Other trials in Burkina Faso

Côte d’Ivoire1 site

  • Institut Pierre Richet

    Bouaké

Other trials in Côte d’Ivoire

About this study

Official title: Insecticide Resistance Management in Burkina Faso and Côte D'Ivoire: Research on Vector Control Strategies

This study evaluates the benefit to use 1) insecticide residual sprayings, 2) larvicides, 3) Ivermectin for domestic animals and 4) behaviour change communication strategy to complement the universal coverage with LLINs through a cluster randomized trial.

Conditions
Malaria
Being tested
Indoor residual sprayings, Larvicide, BCC, Ivermectin
Keywords
Randomized Controlled Trials
Medical subject headings
Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indoor residual sprayingsDevice

    Also called Actellic

    Houses will be spayed with this formulation containing Pyrimiphos methyl.

  • LarvicideDevice

    Larval breeding sites will be treated with larvicide

  • BCCBehavioural

  • IvermectinBiological

Study groups in NCT03074435
Study groupRoleWhat they receive
Control arm (LLIN-alone)No interventionThe baseline and control intervention (LLIN-alone) correspond to what is implemented in each country by their respective National Malaria Control Programs (NMCP). This include universal coverage with Long-Lasting insecticidal Nets (LLIN). This arm is common to both countries (Burkina Faso and Côte d'Ivoire)
LLIN + indoor residual sprayingsExperimentalLLIN+IRS arm consisted in applying, in addition to LLINs, IRS with Actellic® 300CS (Syngenta AG, Basel, Switzerland) at a target dosage of 1 g. of active ingredient (pirimiphos-methyl) per m² in every houses of the selected villages. This arm is common to both countries (Burkina Faso and Côte d'Ivoire)
Receives: Device: Indoor residual sprayings
LLIN + LarvicideExperimentalThe intervention consists in treating Anopheles breeding sites with BTI biological larvicide, in addition to LLINs. This arm was implemented in Côte d'Ivoire only.
Receives: Device: Larvicide
LLIN+ One-health IvermectinExperimentalThis arm consists in monthly injections of ivermectin to peri-domestic farm animals (mammals) during 4 consecutive months, oin addition to LLINs. This arm was implemented in Burkina Faso only.
Receives: Biological: Ivermectin
LLIN + Behaviour Change CommunicationExperimentalBCC complementary intervention (LLIN+BCC arm) was designed to target the following behaviors in the human population: (i) everyone sleep under an LLIN every night, (ii) every household and community member cleans up its environment to limits mosquito proliferation, (iii) every pregnant woman asks for, and takes the intermittent preventive treatment of malaria during pregnancy (ITP) and, (iv) people in charge of <5 y/o children come to see an health worker within 24h in case of fever. The intervention involve one health worker from the community per 35 households. Every health worker has the objective to perform 15 home visits (15-20 min), 20 interpersonal talks (15-20 min) and 4 group talks (15-30 min) per months.
Receives: Behavioral: BCC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Malaria incidence density

    Malaria cases (whole population, every ages) registered in the local health system.

    Measured: continuous monitoring during 2 years

Secondary outcomes (2)

  1. Entomological Inoculation Rate

    Number of infectious bites/personn

    Measured: Every 8 weeks during 2 years

  2. Malaria prevalence

    % of positive blood smears among the 0-18 y/o population as recorded during cross sectional surveys.

    Measured: Every 4 months during 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2017
  2. Study startJul 2016
  3. Primary completionAug 2018
  4. Study completionAug 2018

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a cluster-randomized, parallel with baseline, trial. The study is bi-centric for the evaluation of two arms (LLIN+IRS and LLIN+BCC)
Masking
None (open label)
Enrolment
15,776 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03074435
Sponsor's protocol ID
InstitutRD
Other IDs
15SANIN213
Acronym
REACT
Status last verified
Sep 2024
First submitted
4 Nov 2016
Last updated
1 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bationo CS, Gaudart J, Dieng S, Cissoko M, Taconet P, Ouedraogo B, Some A, Zongo I, Soma DD, Tougri G, Dabire RK, Koffi A, Pennetier C, Moiroux N. Spatio-temporal analysis and prediction of malaria cases using remote sensing meteorological data in Diebougou health district, Burkina Faso, 2016-2017. Sci Rep. 2021 Oct 8;11(1):20027. doi: 10.1038/s41598-021-99457-9.

    PubMed 34625589

  • Taconet P, Porciani A, Soma DD, Mouline K, Simard F, Koffi AA, Pennetier C, Dabire RK, Mangeas M, Moiroux N. Data-driven and interpretable machine-learning modeling to explore the fine-scale environmental determinants of malaria vectors biting rates in rural Burkina Faso. Parasit Vectors. 2021 Jun 29;14(1):345. doi: 10.1186/s13071-021-04851-x.

    PubMed 34187546

  • Soma DD, Zogo B, Taconet P, Some A, Coulibaly S, Baba-Moussa L, Ouedraogo GA, Koffi A, Pennetier C, Dabire KR, Moiroux N. Quantifying and characterizing hourly human exposure to malaria vectors bites to address residual malaria transmission during dry and rainy seasons in rural Southwest Burkina Faso. BMC Public Health. 2021 Jan 30;21(1):251. doi: 10.1186/s12889-021-10304-y.

    PubMed 33516197

  • Soma DD, Zogo B, Hien DFS, Hien AS, Kabore DA, Kientega M, Ouedraogo AG, Pennetier C, Koffi AA, Moiroux N, Dabire RK. Insecticide resistance status of malaria vectors Anopheles gambiae (s.l.) of southwest Burkina Faso and residual efficacy of indoor residual spraying with microencapsulated pirimiphos-methyl insecticide. Parasit Vectors. 2021 Jan 18;14(1):58. doi: 10.1186/s13071-020-04563-8.

    PubMed 33461621

  • Soma DD, Zogo BM, Some A, Tchiekoi BN, Hien DFS, Pooda HS, Coulibaly S, Gnambani JE, Ouari A, Mouline K, Dahounto A, Ouedraogo GA, Fournet F, Koffi AA, Pennetier C, Moiroux N, Dabire RK. Anopheles bionomics, insecticide resistance and malaria transmission in southwest Burkina Faso: A pre-intervention study. PLoS One. 2020 Aug 3;15(8):e0236920. doi: 10.1371/journal.pone.0236920. eCollection 2020.

    PubMed 32745085

  • Zogo B, Soma DD, Tchiekoi BN, Some A, Ahoua Alou LP, Koffi AA, Fournet F, Dahounto A, Coulibaly B, Kande S, Dabire RK, Baba-Moussa L, Moiroux N, Pennetier C. Anopheles bionomics, insecticide resistance mechanisms, and malaria transmission in the Korhogo area, northern Cote d'Ivoire: a pre-intervention study. Parasite. 2019;26:40. doi: 10.1051/parasite/2019040. Epub 2019 Jul 12.

    PubMed 31298995

  • Zogo B, Koffi AA, Alou LPA, Fournet F, Dahounto A, Dabire RK, Baba-Moussa L, Moiroux N, Pennetier C. Identification and characterization of Anopheles spp. breeding habitats in the Korhogo area in northern Cote d'Ivoire: a study prior to a Bti-based larviciding intervention. Parasit Vectors. 2019 Mar 27;12(1):146. doi: 10.1186/s13071-019-3404-0.

    PubMed 30917867

  • Zogo B, Tchiekoi BN, Koffi AA, Dahounto A, Ahoua Alou LP, Dabire RK, Baba-Moussa L, Moiroux N, Pennetier C. Impact of sunlight exposure on the residual efficacy of biolarvicides Bacillus thuringiensis israelensis and Bacillus sphaericus against the main malaria vector, Anopheles gambiae. Malar J. 2019 Feb 26;18(1):55. doi: 10.1186/s12936-019-2687-0.

    PubMed 30808348

  • Moiroux N, Zongo I, Assi SB, Some A, Tchiekoi NB, Zogo B, Soma DD, Hien DFDS, Taconet P, Ahoua Alou LP, Lefevre T, Cohuet A, Fournet F, Mouline K, Koffi AA, Dabire RK, Pennetier C. Efficacy of non-pyrethroid indoor residual spraying or intensive behaviour change communication in combination with long-lasting insecticidal nets for malaria control in west Africa: a pragmatic, cluster-randomised, controlled trial. Lancet Glob Health. 2025 Sep;13(9):e1605-e1616. doi: 10.1016/S2214-109X(25)00216-5.

    PubMed 40845886

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indoor residual sprayings, Larvicide and BCC in people with Malaria, run by Institut de Recherche pour le Developpement at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 1 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 2 sites in Burkina Faso, Côte d’Ivoire. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 incidence density (time frame: continuous monitoring during 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 NCT03074435, which also lists 9 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 1 Oct 2024.

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