MalariaAEGIS MaliNCT04795648
Spatial Repellents for Vector Control
A study testing Transfluthrin in people with Malaria, run by University of Notre Dame at 2 sites in Mali.
Trial summary
The primary objective of the study is to demonstrate and quantify the protective efficacy of a single Spatial Repellent (SR) product, in reducing malaria infection in a human cohort. The study design will be a prospective cluster Randomized Control Trial (cRCT). Read more about this study
- Who is it for?
- Ages 6 months to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Transfluthrin
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,911 participants
- Where
- 2 sitesMali
- Study dates
- 8 Jul 2021to 2 Mar 2024
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children ≥ 6 months to < 10 years of age
- 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
Who cannot join
- Children < 6 months or ≥ 10 years
- 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
Trial locations and contacts
2 sites in 1 country.
Mali2 sites
Catholic Relief Services
Bamako
Malaria Research and Training Center (MRTC), University of Bamako, Mali
Bamako
About this study
Official title: Spatial Repellent Products for Control of Vector Borne Diseases
The primary objective of the study is to demonstrate and quantify the protective efficacy of a single Spatial Repellent (SR) product, in reducing malaria infection in a human cohort. The study design will be a prospective cluster Randomized Control Trial (cRCT).
Read the detailed description
Children ≥ 6 months to < 10 years of age will be enrolled in a single cohort across 60 clusters (30 clusters per treatment arm). The cohort will be followed for 6 months for baseline covariate measurements and 24 months with intervention. Blood samples will be taken once every 4 weeks from all cohort subjects to test for malaria infection and whenever a subject reports a recent history of fever (within previous 48 hours). During follow up of enrolled subjects, study clinicians will have the option to conduct a Hb test for enrolled subjects when they may present signs of anemia to see if they might need additional treatment beyond malaria ACTs (if malaria infection is indicated). Rapid Diagnostic Tests (RDTs) will be used for point-of-care diagnosis of malaria infection with microscopy used to confirm infection status. All positive malaria infections as indicated by either RDT or microscopy, clinical and asymptomatic, will be treated. If a subject has a RDT negative outcome but a positive microscopy diagnosis, follow up treatment for the malaria infection will be provided to the subject within 72hrs of the microscopy read. Cohort subjects who test positive for malaria by either RDT or microscopy, symptomatic or asymptomatic, during both scheduled and unscheduled visits will be treated with ACTs. The incidence of malaria infection will be measured by microscopy and estimated and compared between treatment arms to determine the benefit of using an SR in an area with high, seasonal transmission of malaria.
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
- Malaria
- Being tested
- Transfluthrin, Placebo
- Keywords
- Malaria, Spatial Repellent, Transfluthrin, Vector-borne diseases, Mosquito vectors, Incidence
- Medical subject headings
- Malaria, Vector Borne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransfluthrinDevice
Passive emanator with formulated transfluthrin
PlaceboDevice
Passive emanator with formulated inert ingredients
| Study group | Role | What they receive |
|---|---|---|
| Spatial Repellent | Experimental | Transfluthrin Receives: Device: Transfluthrin |
| Placebo | Placebo comparator | Inert ingredients Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of first-time malaria infections during intervention period.
Measured by microscopy in children aged between 6 months to 10 years.
Measured: 24 months
Secondary outcomes (12)
Number of overall new malaria infections during intervention period.
Measured by microscopy in children aged between 6 months to 10 years.
Measured: 24 months
Parasite-species-specific first-time malaria infections.
Measured by microscopy in children aged between 6 months to 10 years.
Measured: 24 months
Parasite-species-specific overall malaria infections.
Measured by microscopy in children aged between 6 months to 10 years.
Measured: 24 months
Number of first-time malaria infections by two age groups (≤ 59 months old; 5 years old to 10 years old).
Measured by microscopy in children aged between 6 months to 10 years.
Measured: 24 months
Number of overall malaria infections by two age groups (≤ 59 months old; 5 years to 10 years old).
Measured by microscopy in children aged between 6 months to 10 years.
Measured: 24 months
Anopheline-human contact (indoor and outdoor) using human biting rate (HBR) as an indicator for all anophelines and by anopheline species.
Measured by human-landing catch (HLC) during 12-h intervals on a quarterly basis during intervention period.
Measured: 24 months
Anopheline parity rate as an indicator of population age structure for all anophelines and by anopheline species.
Measured by mosquito ovarian dissections from a sub-sample of anophelines collected during HLC procedures during intervention period.
Measured: 24 months
Anopheline infectivity using sporozoite rate as an indicator for all anophelines and by anopheline species.
Measured by laboratory detection of sporozoites in mosquito head-preps from a sub-sample of anophelines collected during HLC and/or CDC-light trap procedures during intervention period.
Measured: 24 months
Anopheline infectivity using entomological inoculation rate (EIR) as an indicator for all anophelines and by anopheline species.
Measured by calculating the number of sporozoite-infected anopheline mosquitoes captured per person during intervention period from HLC and/or CDC-light trap procedures.
Measured: 24 months
CDC-light trap indoor density for all anophelines and by anopheline species.
Measured by CDC-light trap collections during 12-h intervals on a monthly basis during intervention period.
Measured: 24 months
Insecticide resistance.
Measured by WHO filter paper test and CDC bottle assays during baseline and intervention period.
Measured: 30 months
Adverse Events and Serious Adverse Events.
Measured by solicited and unsolicited reports during baseline and intervention period. Mean, minimum and maximum frequency and percentage of Adverse Events(AEs) and Severe Adverse Events (SAEs) across clusters among enrolled subjects will be summarized by treatment arm.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start8 Jul 2021
- Primary completion2 Mar 2024
- Study completion2 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- Model description
- The study design will be a prospective cluster Randomized Control Trial (cRCT)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,911 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Collaborators
- S.C. Johnson & Son, Inc., fhiClinical, Malaria Research and Training Center, Bamako, Mali, Catholic Relief Services
- Responsible party
- Sponsor
- Investigators
- John P Grieco, Ph.D., Study director, University of Notre DameSuzanne Van Hulle, M.H.S, Principal investigator, Catholic Relief Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795648
- Sponsor's protocol ID
- 20-10-6245
- Acronym
- AEGIS Mali
- Status last verified
- Apr 2024
- First submitted
- 9 Mar 2021
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Analytical datasets will be anonymized and GPS tag-blurred to remove sensitive information prior to sharing.
Publications
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.
PubMed 22583679Cisse 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.
PubMed 26296644Fanello 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.
PubMed 12752657Hill 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.
PubMed 24885993Kawada 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.
PubMed 18939693Keita 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.
PubMed 26740098Lucas 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.
PubMed 17536367Ogoma 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.
PubMed 23216844Syafruddin 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.
PubMed 25311699Tripet 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.
PubMed 17255234Van 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.
PubMed 35382856
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Repellent Products for Control of Vector Borne Diseases
- ClinicalTrials.gov ID
- NCT04795648
- Acronym / sponsor ID
- AEGIS Mali / 20-10-6245
- Conditions
- Malaria
- Keywords
- Malaria, Spatial Repellent, Transfluthrin, Vector-borne diseases, Mosquito vectors, Incidence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,911 participants (actual)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Collaborators
- S.C. Johnson & Son, Inc., fhiClinical, Malaria Research and Training Center, Bamako, Mali, Catholic Relief Services
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 2 Mar 2024 (actual)
- Study completion
- 2 Mar 2024 (actual)
- First posted
- 12 Mar 2021 (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 primary objective of the study is to demonstrate and quantify the protective efficacy of a single Spatial Repellent (SR) product, in reducing malaria infection in a human cohort. The study design will be a prospective cluster Randomized Control Trial (cRCT).
Detailed description
Children ≥ 6 months to < 10 years of age will be enrolled in a single cohort across 60 clusters (30 clusters per treatment arm). The cohort will be followed for 6 months for baseline covariate measurements and 24 months with intervention. Blood samples will be taken once every 4 weeks from all cohort subjects to test for malaria infection and whenever a subject reports a recent history of fever (within previous 48 hours). During follow up of enrolled subjects, study clinicians will have the option to conduct a Hb test for enrolled subjects when they may present signs of anemia to see if they might need additional treatment beyond malaria ACTs (if malaria infection is indicated). Rapid Diagnostic Tests (RDTs) will be used for point-of-care diagnosis of malaria infection with microscopy used to confirm infection status. All positive malaria infections as indicated by either RDT or microscopy, clinical and asymptomatic, will be treated. If a subject has a RDT negative outcome but a positive microscopy diagnosis, follow up treatment for the malaria infection will be provided to the subject within 72hrs of the microscopy read. Cohort subjects who test positive for malaria by either RDT or microscopy, symptomatic or asymptomatic, during both scheduled and unscheduled visits will be treated with ACTs. The incidence of malaria infection will be measured by microscopy and estimated and compared between treatment arms to determine the benefit of using an SR in an area with high, seasonal transmission of malaria.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study design will be a prospective cluster Randomized Control Trial (cRCT)
| Arm | Type | Receives |
|---|---|---|
| Spatial Repellent | Experimental | Device: TransfluthrinTransfluthrin |
| Placebo | Placebo comparator | Device: PlaceboInert ingredients |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children ≥ 6 months to < 10 years of age
- 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
Key exclusion criteria (5 listed)
- Children < 6 months or ≥ 10 years
- 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
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 |
|---|---|---|
| TransfluthrinPassive emanator with formulated transfluthrin | Device | Spatial Repellent |
| PlaceboPassive emanator with formulated inert ingredients | Device | Placebo |
Primary outcome
Number of first-time malaria infections during intervention period.
Time frame: 24 months
Measured by microscopy in children aged between 6 months to 10 years.
12 secondary outcomes
Number of overall new malaria infections during intervention period.
Time frame: 24 months
Parasite-species-specific first-time malaria infections.
Time frame: 24 months
Parasite-species-specific overall malaria infections.
Time frame: 24 months
Number of first-time malaria infections by two age groups (≤ 59 months old; 5 years old to 10 years old).
Time frame: 24 months
Number of overall malaria infections by two age groups (≤ 59 months old; 5 years to 10 years old).
Time frame: 24 months
Anopheline-human contact (indoor and outdoor) using human biting rate (HBR) as an indicator for all anophelines and by anopheline species.
Time frame: 24 months
Anopheline parity rate as an indicator of population age structure for all anophelines and by anopheline species.
Time frame: 24 months
Anopheline infectivity using sporozoite rate as an indicator for all anophelines and by anopheline species.
Time frame: 24 months
Anopheline infectivity using entomological inoculation rate (EIR) as an indicator for all anophelines and by anopheline species.
Time frame: 24 months
CDC-light trap indoor density for all anophelines and by anopheline species.
Time frame: 24 months
Insecticide resistance.
Time frame: 30 months
Adverse Events and Serious Adverse Events.
Time frame: 30 months
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 2 Apr 2024.
- Background: PubMed 22583679Achee 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.
- Background: PubMed 26296644Cisse 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.
- Background: PubMed 12752657Fanello 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.
- Background: PubMed 24885993Hill 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.
- Background: PubMed 18939693Kawada 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.
- Background: PubMed 26740098Keita 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.
- Background: PubMed 17536367Lucas 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.
- Background: PubMed 23216844Ogoma 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.
- Background: PubMed 25311699Syafruddin 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.
- Background: PubMed 17255234Tripet 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.
- Derived from this study: PubMed 35382856Van 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.
- Demographic Health Survey, Mali, 2018Link provided by the sponsor.
- Demographic Health Survey, Mali, 2015Link provided by the sponsor.
- Health Management Information System, DHIS2, 2018Link provided by the sponsor.
- Recensement General de la Population et de l'Habitat du Mali (RGPH) 2009Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Analytical datasets will be anonymized and GPS tag-blurred to remove sensitive information prior to sharing.
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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.
John P Grieco, Ph.D. study director
University of Notre Dame
Suzanne Van Hulle, M.H.S principal investigator
Catholic Relief Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transfluthrin in people with Malaria, run by University of Notre Dame at 2 sites in Mali.
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 5 inclusion and 5 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 2 Apr 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 Mali. 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. Some participants in this study may receive a placebo. 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?
Number of first-time malaria infections during intervention period. (time frame: 24 months). 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 NCT04795648, which also lists 11 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 2 Apr 2024.