Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1911 participants
INTERVENTIONAL
2021-07-08
2024-03-02
Brief Summary
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Detailed Description
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Entomological endpoints of exposure risk to mosquitoes will also be measured to identify entomological correlates of SR efficacy that may be useful for the evaluation of new SR products. Twenty clusters (10 SR, 10 placebo) will be randomly selected to estimate the impact of the SR on entomological measures of malaria transmission. Within each cluster, light trap collections will be conducted monthly in 10 randomly selected households to assess the impact of SRs on the density of Anopheles mosquitoes indoors. Human landing catches will be done indoors and outdoors in 6 intervention and 6 control clusters (the 12 clusters will remain fixed throughout the study) in four houses (randomly selected) in each cluster for the period of 2 nights (total of 48 houses across both arms) once every quarter (3 months) to determine the effect of SR on the host seeking behavior of mosquitoes.
The SR will be a new formulation of transfluthrin. This active ingredient (AI) is widely used in mosquito coils and other household pest control products. The new formulation is a passive emanator that will release the AI over a period of up to four weeks. The emanator will consist of a pre-treated piece of cellulose acetate, which will be positioned within consenting households according to manufacturer specifications. The SRs and placebos for this study will be designed and manufactured by S.C. Johnson, Inc. USA.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Spatial Repellent
Transfluthrin
Transfluthrin
Passive emanator with formulated transfluthrin
Placebo
Inert ingredients
Placebo
Passive emanator with formulated inert ingredients
Interventions
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Transfluthrin
Passive emanator with formulated transfluthrin
Placebo
Passive emanator with formulated inert ingredients
Eligibility Criteria
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Inclusion Criteria
* Children with Hb \> 7 g/dL and no signs of known chronic disease or other other serious illness
* Sleeps in cluster ≥ 90% of nights during any given month
* Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
* Provision of informed consent (and/or assent) form (ICF) signed by the parent(s) or guardian
Exclusion Criteria
* Childrend with Hb \<= 7 g/dL with signs of known chronic disease or other serious illness, or Hb \<6 g/dL with signs of clinical decompensation
* Sleeps in cluster \<90% of nights during any given month
* Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
* No provision of ICF (and/or assent) signed by the parent(s) or guardian
6 Months
10 Years
ALL
Yes
Sponsors
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S.C. Johnson & Son, Inc.
INDUSTRY
fhiClinical
UNKNOWN
Malaria Research and Training Center, Bamako, Mali
OTHER
Catholic Relief Services
OTHER
University of Notre Dame
OTHER
Responsible Party
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Principal Investigators
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John P Grieco, Ph.D.
Role: STUDY_DIRECTOR
University of Notre Dame
Suzanne Van Hulle, M.H.S
Role: PRINCIPAL_INVESTIGATOR
Catholic Relief Services
Locations
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Catholic Relief Services
Bamako, , Mali
Malaria Research and Training Center (MRTC), University of Bamako, Mali
Bamako, , Mali
Countries
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References
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Achee NL, Bangs MJ, Farlow R, Killeen GF, Lindsay S, Logan JG, Moore SJ, Rowland M, Sweeney K, Torr SJ, Zwiebel LJ, Grieco JP. Spatial repellents: from discovery and development to evidence-based validation. Malar J. 2012 May 14;11:164. doi: 10.1186/1475-2875-11-164.
Cisse MB, Keita C, Dicko A, Dengela D, Coleman J, Lucas B, Mihigo J, Sadou A, Belemvire A, George K, Fornadel C, Beach R. Characterizing the insecticide resistance of Anopheles gambiae in Mali. Malar J. 2015 Aug 22;14:327. doi: 10.1186/s12936-015-0847-4.
Fanello C, Petrarca V, della Torre A, Santolamazza F, Dolo G, Coulibaly M, Alloueche A, Curtis CF, Toure YT, Coluzzi M. The pyrethroid knock-down resistance gene in the Anopheles gambiae complex in Mali and further indication of incipient speciation within An. gambiae s.s. Insect Mol Biol. 2003 Jun;12(3):241-5. doi: 10.1046/j.1365-2583.2003.00407.x.
Hill N, Zhou HN, Wang P, Guo X, Carneiro I, Moore SJ. A household randomized, controlled trial of the efficacy of 0.03% transfluthrin coils alone and in combination with long-lasting insecticidal nets on the incidence of Plasmodium falciparum and Plasmodium vivax malaria in Western Yunnan Province, China. Malar J. 2014 May 31;13:208. doi: 10.1186/1475-2875-13-208.
Kawada H, Temu EA, Minjas JN, Matsumoto O, Iwasaki T, Takagi M. Field evaluation of spatial repellency of metofluthrin-impregnated plastic strips against Anopheles gambiae complex in Bagamoyo, coastal Tanzania. J Am Mosq Control Assoc. 2008 Sep;24(3):404-9. doi: 10.2987/5743.1.
Keita M, Traore S, Sogoba N, Dicko AM, Coulibaly B, Sacko A, Doumbia S, Traore SF. [Susceptibility status of Anopheles gambiae sensu lato to insecticides commonly used for malaria control in Mali]. Bull Soc Pathol Exot. 2016 Feb;109(1):39-45. doi: 10.1007/s13149-015-0461-2. Epub 2016 Jan 6. French.
Lucas JR, Shono Y, Iwasaki T, Ishiwatari T, Spero N, Benzon G. U.S. laboratory and field trials of metofluthrin (SumiOne) emanators for reducing mosquito biting outdoors. J Am Mosq Control Assoc. 2007 Mar;23(1):47-54. doi: 10.2987/8756-971X(2007)23[47:ULAFTO]2.0.CO;2.
Ogoma SB, Moore SJ, Maia MF. A systematic review of mosquito coils and passive emanators: defining recommendations for spatial repellency testing methodologies. Parasit Vectors. 2012 Dec 7;5:287. doi: 10.1186/1756-3305-5-287.
Syafruddin D, Bangs MJ, Sidik D, Elyazar I, Asih PB, Chan K, Nurleila S, Nixon C, Hendarto J, Wahid I, Ishak H, Bogh C, Grieco JP, Achee NL, Baird JK. Impact of a spatial repellent on malaria incidence in two villages in Sumba, Indonesia. Am J Trop Med Hyg. 2014 Dec;91(6):1079-87. doi: 10.4269/ajtmh.13-0735. Epub 2014 Oct 13.
Tripet F, Wright J, Cornel A, Fofana A, McAbee R, Meneses C, Reimer L, Slotman M, Thiemann T, Dolo G, Traore S, Lanzaro G. Longitudinal survey of knockdown resistance to pyrethroid (kdr) in Mali, West Africa, and evidence of its emergence in the Bamako form of Anopheles gambiae s.s. Am J Trop Med Hyg. 2007 Jan;76(1):81-7.
Van Hulle S, Sagara I, Mbodji M, Nana GI, Coulibaly M, Dicko A, Kone M, Thera I, Sylla D, Traore MD, Liu F, Grieco JP, Achee NL. Evaluation of the protective efficacy of a spatial repellent to reduce malaria incidence in children in Mali compared to placebo: study protocol for a cluster-randomized double-blinded control trial (the AEGIS program). Trials. 2022 Apr 5;23(1):259. doi: 10.1186/s13063-022-06197-w.
Related Links
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Annuaire Statistique 2018 du Systeme Local d'Information Sanitaire (SLIS) du Mali, 2018
Demographic Health Survey, Mali, 2018
Demographic Health Survey, Mali, 2015
Health Management Information System, DHIS2, 2018
Recensement General de la Population et de l'Habitat du Mali (RGPH) 2009
Other Identifiers
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20-10-6245
Identifier Type: -
Identifier Source: org_study_id
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