Attractive Targeted Sugar Bait Trial in Mali

NCT04149119 | Unknown DMC

• 1 other identifier: 6719882
• Study Type: interventional
• Target: 2,100
• Locations: 1 country
• Sites: 1

Brief Summary

Globally, the female mosquitoes to be effective at transmitting malaria parasites, must have a number of characteristics including: abundance, longevity (individual mosquitoes must survive long enough after feeding on infected blood to allow the parasite time to develop and travel to the mosquito's salivary glands), capacity (each female mosquito must be both susceptible to infection with Plasmodium and able to carry enough malaria parasites in the salivary glands), contact with humans (frequently feed on humans). Vectors in SSA are often anthropophagic and anthropophilic, and exhibit indoor biting and indoor resting behavior. Highly effective interventions against vectors have been developed and implemented at scale (e.g., indoor Residual Spraying of Insecticides \[IRS\] and Long Lasting Insecticide-treated Nets \[LLINs\]). While these interventions have contributed importantly to the reduction of malaria transmission and disease (68% and 11% respectively), none of them target outdoor-biting g and outdoor-resting mosquitoes. Given the increase in resistance to current generation of insecticides and the behavioral plasticity of vectors that results in continued malaria transmission despite high coverage of LLINs or IRS, there is a need for interventions that can supplement and complement LLINs and IRS by killing mosquitoes outside houses using other biologic mechanisms (e.g., targeting sugar feeding behavior). Finally, insecticides with novel modes of action that may be capable of restoring sensitivity to pyrethroids by killing both pyrethroid resistant and sensitive mosquitoes are required. Attractive Target Sugar Baits (ATSBs) that kill mosquitoes through the ingestion of the toxicant dinotefuran (and possibly by other ingestion toxicants that are effective when ingested) potentially fill the need for outdoor interventions with novel killing effects. This study aims to establish the efficacy and contribution of the ATSBs for controlling malaria transmission where An. gambiae s.l. and An. Funestus are the major vectors for malaria.

Conditions

Vector Transmission

Keywords

Malaria; Vector control; ATSB; Transmission; Mali

Outcome Measures

Primary Outcomes (1)

• Malaria incidence per person times

  Malaria case incidence (the total number of incident malaria cases detected by RDT divided by the total person-time followed up in cohorts) will be assessed among people aged 5 to \< 15 years old

  Through study completion (average 2 years

Secondary Outcomes (1)

• Incidence of malaria per person times using molecular analysis tools

  Through study completion (average 2 years

Other Outcomes (1)

• Community acceptance of ATSBs in intervention area

  Through study completion (average 2 years

Study Arms (2)

Intervention arm

EXPERIMENTAL

ATSB+LLINs+Standard Care for Malaria case management

Device: Attractive Target Sugar Baits (ATSB)

Standard arm or arm 2

NO INTERVENTION

LLINs+Standard Care for MalarIA case management

Interventions

Attractive Target Sugar Baits (ATSB) DEVICE

Within the intervention area, a total of four ATSB station will be deployed (external wall). ATSB stations will be monitored by community health workers through weekly visit and all stations will be replaced 6months after deployment.

Intervention arm

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Household resident of the selected villages
• Aged 5 to 14 years of age at the time of enrollment
• All parents or guardians provide consent for their child's participant (5-14 years old)
• If age 12 - 14 years, the child also provides assent for participation
• Absence of pregnancy

You may not qualify if:

• Not resident of any household within the selected villages
• Children below 5 years old
• Aged 15 years and older
• Pregnancy
• Do not consent or assent (14 years old)

Sponsors & Collaborators

• University Clinical Research Center, Mali: lead

Study Sites (1)

University Clinical Research Center

Bamako, 5445, Mali

Location

Related Publications (20)

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  PMID: 22475528 BACKGROUND

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  PMID: 26375008 BACKGROUND

• Ranson H, Lissenden N. Insecticide Resistance in African Anopheles Mosquitoes: A Worsening Situation that Needs Urgent Action to Maintain Malaria Control. Trends Parasitol. 2016 Mar;32(3):187-196. doi: 10.1016/j.pt.2015.11.010. Epub 2016 Jan 27.

  PMID: 26826784 BACKGROUND

• Amek N, Bayoh N, Hamel M, Lindblade KA, Gimnig JE, Odhiambo F, Laserson KF, Slutsker L, Smith T, Vounatsou P. Spatial and temporal dynamics of malaria transmission in rural Western Kenya. Parasit Vectors. 2012 Apr 28;5:86. doi: 10.1186/1756-3305-5-86.

  PMID: 22541138 BACKGROUND

• Moiroux N, Damien GB, Egrot M, Djenontin A, Chandre F, Corbel V, Killeen GF, Pennetier C. Human exposure to early morning Anopheles funestus biting behavior and personal protection provided by long-lasting insecticidal nets. PLoS One. 2014 Aug 12;9(8):e104967. doi: 10.1371/journal.pone.0104967. eCollection 2014.

  PMID: 25115830 BACKGROUND

• Sougoufara S, Diedhiou SM, Doucoure S, Diagne N, Sembene PM, Harry M, Trape JF, Sokhna C, Ndiath MO. Biting by Anopheles funestus in broad daylight after use of long-lasting insecticidal nets: a new challenge to malaria elimination. Malar J. 2014 Mar 28;13:125. doi: 10.1186/1475-2875-13-125.

  PMID: 24678587 BACKGROUND

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  PMID: 25149656 BACKGROUND

• Killeen GF, Marshall JM, Kiware SS, South AB, Tusting LS, Chaki PP, Govella NJ. Measuring, manipulating and exploiting behaviours of adult mosquitoes to optimise malaria vector control impact. BMJ Glob Health. 2017 Apr 26;2(2):e000212. doi: 10.1136/bmjgh-2016-000212. eCollection 2017.

  PMID: 28589023 BACKGROUND

• Zhu L, Muller GC, Marshall JM, Arheart KL, Qualls WA, Hlaing WM, Schlein Y, Traore SF, Doumbia S, Beier JC. Is outdoor vector control needed for malaria elimination? An individual-based modelling study. Malar J. 2017 Jul 3;16(1):266. doi: 10.1186/s12936-017-1920-y.

  PMID: 28673298 BACKGROUND

• Muller GC and Galili A. (2016). Attractive toxic sugar baits (ATSB): from basic science to product- a new paradigm for vector control. Roll Back Malaria, Vector Control Working Group meeting presentation.

  BACKGROUND

• Beier JC, Muller GC, Gu W, Arheart KL, Schlein Y. Attractive toxic sugar bait (ATSB) methods decimate populations of Anopheles malaria vectors in arid environments regardless of the local availability of favoured sugar-source blossoms. Malar J. 2012 Feb 1;11:31. doi: 10.1186/1475-2875-11-31.

  PMID: 22297155 BACKGROUND

• Muller GC, Beier JC, Traore SF, Toure MB, Traore MM, Bah S, Doumbia S, Schlein Y. Field experiments of Anopheles gambiae attraction to local fruits/seedpods and flowering plants in Mali to optimize strategies for malaria vector control in Africa using attractive toxic sugar bait methods. Malar J. 2010 Sep 20;9:262. doi: 10.1186/1475-2875-9-262.

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  PMID: 25899397 BACKGROUND

• Marshall JM, White MT, Ghani AC, Schlein Y, Muller GC, Beier JC. Quantifying the mosquito's sweet tooth: modelling the effectiveness of attractive toxic sugar baits (ATSB) for malaria vector control. Malar J. 2013 Aug 23;12:291. doi: 10.1186/1475-2875-12-291.

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• WHO. (2017). Malaria vector control policy recommendations and their applicability to product evaluation. Geneva: WHO.

  BACKGROUND

• Midega JT, Mbogo CM, Mwnambi H, Wilson MD, Ojwang G, Mwangangi JM, Nzovu JG, Githure JI, Yan G, Beier JC. Estimating dispersal and survival of Anopheles gambiae and Anopheles funestus along the Kenyan coast by using mark-release-recapture methods. J Med Entomol. 2007 Nov;44(6):923-9. doi: 10.1603/0022-2585(2007)44[923:edasoa]2.0.co;2.

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• Gimnig JE, Walker ED, Otieno P, Kosgei J, Olang G, Ombok M, Williamson J, Marwanga D, Abong'o D, Desai M, Kariuki S, Hamel MJ, Lobo NF, Vulule J, Bayoh MN. Incidence of malaria among mosquito collectors conducting human landing catches in western Kenya. Am J Trop Med Hyg. 2013 Feb;88(2):301-8. doi: 10.4269/ajtmh.2012.12-0209. Epub 2012 Dec 18.

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• Sarrassat S, Toure M, Diarra A, Keita M, Coulibaly H, Arou AZ, Traore M, Tangara CO, Bradley J, Muller G, Majambere S, Beier JC, Vontas J, Traore SF, Diop S, Kleinschmidt I, Doumbia S. Evaluation of Attractive Targeted Sugar Baits, a new outdoor vector control strategy against malaria: Results from a cluster randomised open-label parallel arm controlled trial in Southwestern Mali. J Infect. 2025 Jul;91(1):106524. doi: 10.1016/j.jinf.2025.106524. Epub 2025 Jun 5.

  PMID: 40482859 DERIVED

• Attractive Targeted Sugar Bait Phase III Trial Group. Attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia. Trials. 2022 Aug 9;23(1):640. doi: 10.1186/s13063-022-06555-8.

  PMID: 35945599 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Seydou Doumbia, PhD

  University Clinical Research Center - USTTB - Mali

  STUDY DIRECTOR

Central Study Contacts

Seydou Doumbia, PhD

CONTACT

+223 76461339; sdoumbi@gmail.com

Mahamoudou Toure, MD-PsPH

CONTACT

+22366778912; mah.toure@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An open-label two-arm cluster randomized controlled trial (CRCT) design will be used comparing ATSB + LLINS vs LLINS alone (standard of care). A cluster trial design is indicated given the intended community-level effect of ATSBs on malaria transmission. Universal LLIN coverage will be ensured in both arms prior to start of the study and will serve as the standard of care. Arm 1 will receive ATSBs for two years. Arm 2 will receive the standard of care of universal LLIN coverage. The incidence cohorts will be powered to detect a 30% reduction in incidence assuming follow-up over a two year period (see sample size section). Prevalence of infection will be powered to detect a 30% lower prevalence in the treatment arm of of the trial during each of the two post randomisation cross sectional surveys.

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: November 4, 2019
• Study Start: May 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: July 7, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)