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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03074435




Registration number
NCT03074435
Ethics application status
Date submitted
4/11/2016
Date registered
8/03/2017
Date last updated
1/10/2024

Titles & IDs
Public title
Insecticide Resistance Management in Burkina Faso and Côte D'Ivoire
Scientific title
Insecticide Resistance Management in Burkina Faso and Côte D'Ivoire: Research on Vector Control Strategies
Secondary ID [1] 0 0
15SANIN213
Secondary ID [2] 0 0
InstitutRD
Universal Trial Number (UTN)
Trial acronym
REACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Indoor residual sprayings
Treatment: Devices - Larvicide

No intervention: Control arm (LLIN-alone) - The 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)

Experimental: LLIN + indoor residual sprayings - LLIN+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)

Experimental: LLIN + Larvicide - The intervention consists in treating Anopheles breeding sites with BTI biological larvicide, in addition to LLINs. This arm was implemented in Côte d'Ivoire only.

Experimental: LLIN+ One-health Ivermectin - This 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.

Experimental: LLIN + Behaviour Change Communication - BCC 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.


Treatment: Devices: Indoor residual sprayings
Houses will be spayed with this formulation containing Pyrimiphos methyl.

Treatment: Devices: Larvicide
Larval breeding sites will be treated with larvicide
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Malaria incidence density
Timepoint [1] 0 0
continuous monitoring during 2 years
Secondary outcome [1] 0 0
Entomological Inoculation Rate
Timepoint [1] 0 0
Every 8 weeks during 2 years
Secondary outcome [2] 0 0
Malaria prevalence
Timepoint [2] 0 0
Every 4 months during 2 years

Eligibility
Key inclusion criteria
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.
Minimum age
No limit
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2018
Sample size
Target
Accrual to date
Final
15776
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Burkina Faso
State/province [1] 0 0
Bobo-Dioulasso
Country [2] 0 0
Côte D'Ivoire
State/province [2] 0 0
Bouaké

Funding & Sponsors
Primary sponsor type
Government body
Name
Institut de Recherche pour le Developpement
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Institut de Recherche en Sciences de la Sante, Burkina Faso
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Institut Pierre Richet
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT03074435
Trial related presentations / 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.
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.
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.
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.
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.
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.
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.
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.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Cédric Pennetier, PhD
Address 0 0
Institut de Rehcerche pour le Développement
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03074435