MalariaAEGIS KenyaNCT04766879
Spatial Repellents for the Prevention of Malaria in Kenya
A study testing Transfluthrin in people with Malaria, run by University of Notre Dame at 2 sites in Kenya.
Trial summary
Spatial repellents are chemical-based devices that when placed in a room, make that room non-conducive for mosquitoes. These tools can be used to help in the fight against vector borne diseases such as malaria and dengue. 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
- 5,984 participants
- Where
- 2 sitesKenya
- Study dates
- 2 Mar 2021to 9 Dec 2023
- 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 aged 6 months to <10 years
- Hb > 5mg/dl
- Sleeps in cluster >90% of nights during any given month
- No plans for extended travel (>1month) outside of home during study
- Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the Trial
- Provision of informed consent form signed by the parent(s) or guardian
- Children not on regular malaria prophylaxis° such as Proguanil
- Willingness to take AL and no history of hypersensitivity to AL
Who cannot join
- Children < 6 months or ≥ 10 years
- Hb ≤ 5 mg/dL, or Hb < 6mg/dL with signs of clinical decompensation
- Sleeps in cluster <90% of nights during any given month
- Plans for extended travel (>1month) outside of home during study
- Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
- No provision of informed consent form signed by the parent(s) or guardian
Show all 9Show fewer
- Children on regular malaria prophylaxis° such as Proguanil
- Unwillingness or refusal to take AL and history of AL hypersensitivity
- Other malaria prophylaxis medicines: Mefloquine, Atavaquone/Proguanil (Malarone), Doxycycline, Tafenoquine, Sulfadoxine-Pyrimethamine (Fansidar), Amodiaquine and Co-trimoxazole (Septrin)
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites
Centers for Disease Control and Prevention
Busia, Busia County
Kenya Medical Research Institute (KEMRI)
Busia, Busia County
About this study
Official title: A Cluster Randomized Trial of the Efficacy of a Spatial Repellent (the Envelope) on Plasmodium Falciparum Malaria Incidence as Measured by Time to First Infection in Western Kenya
Spatial repellents are chemical-based devices that when placed in a room, make that room non-conducive for mosquitoes. These tools can be used to help in the fight against vector borne diseases such as malaria and dengue. However, their efficacy in reducing mosquito biting and therefore malaria transmission has never been evaluated in Africa. This study will evaluate the efficacy of a spatial repellent in reducing mosquito biting on human beings and measure the impact any reduced biting will have on malaria transmission. The investigators will recruit and follow-up 5,984 children between 6 months and <10 years of age in Busia County to determine how many times they will be infected with malaria in villages where the investigators will have distributed spatial repellents and compare the rate of infection to villages where the investigators will not have distributed the repellent devices. Additionally, the investigators will measure whether the distribution of spatial repellents in one village will drive mosquitoes to their neighboring houses thereby increasing malaria transmission in those areas. The children participating in the study will be divided into 3 groups (cohorts). The first group will be followed up during the first 4 months before any intervention is distributed and the purpose here will be to determine that the villages are comparable. After this, the investigators will recruit the next group of participants and follow them up for 1 year and repeat this again for another year. During the follow-up, the children will be asked to come to the health facility where they will be tested for malaria using RDT or blood slide for microscopy. Every two weeks, a member of the study team will come to the participant's house and ask them if they had any history of fever. If the participants had fever, they will be tested for malaria. All children who turn out to be positive for malaria by RDT will be treated free of charge. At the same time, the investigators shall also perform mosquito collections to determine the impact of spatial repellents on the density of Anopheles mosquitoes.
Read the detailed description
Spatial repellents (SRs) have been widely used for the prevention of mosquito bites but their protective efficacy (PE) in reducing mosquito-borne diseases has never been evaluated in Africa. To address this knowledge gap, western Kenya was selected as a site to estimate the impact of a transfluthrin-based spatial repellent on malaria-related outcomes in Busia County, where baseline malaria transmission ranges from 2.5 to 4.1 new infections per person per year.
A total of 5,984 children between 6 months and <10 years of age will be enrolled in three separate cohorts (baseline, cohort 1 and cohort 2). A total of 2,040 children from among 60 clusters will be enrolled for a four-month baseline prior to placement of the SR intervention. After baseline, a total of 1,972 participants from among 58 clusters, will be enrolled into cohort 1 and followed for one year. Cohort 2, consisting of a total of 1,972 children, will be enrolled from among 58 clusters to provide a total of two years of follow up. Children who have been selected for inclusion in the baseline cohort will be eligible for selection to cohort 1 or 2 but not both.
Cohort 1 and Cohort 2 during intervention will be split into two groups, one to estimate the direct effect of the SR (total of 1,624 children, 812 per follow up year) and a second to estimate the degree of diversion (or mass effect) of mosquitoes and malaria transmission from persons protected by the SR to persons who are unprotected (total of 2,320 children, 1,160 per follow up year). All cohorts will be followed once every two weeks with finger prick blood samples taken once every 4 weeks to test for malaria or whenever a participant reports a recent (within 48 hours) history of fever.
The incidence of malaria in the baseline cohort will be used to validate underlying assumptions prior to intervention. The incidence of malaria in each cohort followed with intervention will be estimated and compared to determine the benefit of using an SR in an area with high, year-round transmission of malaria. Monthly collections of mosquitoes using CDC light traps will be conducted to determine if there are entomological correlates of SR efficacy that may be useful for the evaluation of new SR products. Quarterly human landing catches will be done to assess the behavioral effects of the SR. The primary hypothesis on PE against the first-time malaria infection will be estimated by comparing the hazard rates of first-time malaria infection between SR and placebo upon the completion of the study in the ITT population.
- 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.
First-time malaria infection in core zones during intervention period.
Measured by microscopy in children aged between 6 months to 10 years.
Measured: 12 months
Secondary outcomes (14)
Overall new malaria infections in core zones during intervention period.
Measured by microscopy in children aged between 6 months to 10 years.
Measured: 12 months
Overall new malaria infections in buffer zones during intervention period.
Measured by microscopy in children aged between 6 months to 10 years.
Measured: 12 months
Parasite-species-specific first-time malaria infections in the core zones.
Measured by microscopy in children aged between 6 months to 10 years.
Measured: 12 months
Parasite-species-specific overall malaria infections in the core zones.
Measured by microscopy in children aged between 6 months to 10 years.
Measured: 12 months
The first-time malaria infections in buffer zones during intervention period.
Measured by microscopy in children aged between 6 months to 10 years.
Measured: 12 months
The first time 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: 12 months
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: 12 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: 12 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: 12 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: 12 months
Anopheline infectivity using 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: 12 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: 12 months
Insecticide resistance.
Measured by WHO filter paper test and CDC bottle assays during baseline and intervention period.
Measured: 28 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 AEs and SAEs across clusters among enrolled subjects will be summarized by treatment arm.
Measured: 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start2 Mar 2021
- Primary completion23 Oct 2023
- Study completion9 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5,984 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Collaborators
- S.C. Johnson & Son, Inc., Kenya Medical Research Institute, Centers for Disease Control and Prevention, fhiClinical
- Responsible party
- Sponsor
- Investigators
- John P Grieco, Ph.D., Study director, University of Notre DameEric Ochomo, Ph.D., Principal investigator, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766879
- Sponsor's protocol ID
- 19-08-5506
- Acronym
- AEGIS Kenya
- Status last verified
- Apr 2024
- First submitted
- 8 Feb 2021
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Analytical data will be anonymized and GPS tag-blurred to remove sensitive information prior to sharing.
Publications
Hamel MJ, Adazu K, Obor D, Sewe M, Vulule J, Williamson JM, Slutsker L, Feikin DR, Laserson KF. A reversal in reductions of child mortality in western Kenya, 2003-2009. Am J Trop Med Hyg. 2011 Oct;85(4):597-605. doi: 10.4269/ajtmh.2011.10-0678.
PubMed 21976557Zhou G, Afrane YA, Vardo-Zalik AM, Atieli H, Zhong D, Wamae P, Himeidan YE, Minakawa N, Githeko AK, Yan G. Changing patterns of malaria epidemiology between 2002 and 2010 in Western Kenya: the fall and rise of malaria. PLoS One. 2011;6(5):e20318. doi: 10.1371/journal.pone.0020318. Epub 2011 May 23.
PubMed 21629783Ogoma 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 23216844Ogoma SB, Ngonyani H, Simfukwe ET, Mseka A, Moore J, Killeen GF. Spatial repellency of transfluthrin-treated hessian strips against laboratory-reared Anopheles arabiensis mosquitoes in a semi-field tunnel cage. Parasit Vectors. 2012 Mar 20;5:54. doi: 10.1186/1756-3305-5-54.
PubMed 22433128Ogoma SB, Ngonyani H, Simfukwe ET, Mseka A, Moore J, Maia MF, Moore SJ, Lorenz LM. The mode of action of spatial repellents and their impact on vectorial capacity of Anopheles gambiae sensu stricto. PLoS One. 2014 Dec 8;9(12):e110433. doi: 10.1371/journal.pone.0110433. eCollection 2014.
PubMed 25485850Achee 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 22583679Lucas 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 17536367Kawada 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 18939693Syafruddin 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 25311699Hill 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 24885993Ochomo EO, Gimnig JE, Awori Q, Abong'o B, Oria P, Ashitiba NK, Polo B, Moshi V, Otanga H, Adung'o F, Ouma EA, Outa S, Ramaita E, Levine R, Odongo W, Harvey SA, Monroe A, Hudson A, Sandberg B, Hendrickson J, Zhao X, Zhou R, Liu F, Achee NL, Grieco JP. Effect of a spatial repellent on malaria incidence in an area of western Kenya characterised by high malaria transmission, insecticide resistance, and universal coverage of insecticide treated nets (part of the AEGIS Consortium): a cluster-randomised, controlled trial. Lancet. 2025 Jan 11;405(10473):147-156. doi: 10.1016/S0140-6736(24)02253-0. Epub 2024 Dec 19.
PubMed 39709979Ochomo EO, Gimnig JE, Bhattarai A, Samuels AM, Kariuki S, Okello G, Abong'o B, Ouma EA, Kosgei J, Munga S, Njagi K, Odongo W, Liu F, Grieco JP, Achee NL. Evaluation of the protective efficacy of a spatial repellent to reduce malaria incidence in children in western Kenya compared to placebo: study protocol for a cluster-randomized double-blinded control trial (the AEGIS program). Trials. 2022 Apr 5;23(1):260. doi: 10.1186/s13063-022-06196-x.
PubMed 35382858
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Trial of the Efficacy of a Spatial Repellent (the Envelope) on Plasmodium Falciparum Malaria Incidence as Measured by Time to First Infection in Western Kenya
- ClinicalTrials.gov ID
- NCT04766879
- Acronym / sponsor ID
- AEGIS Kenya / 19-08-5506
- Conditions
- Malaria
- Keywords
- Malaria, Spatial Repellent, Transfluthrin, Vector-borne diseases, Mosquito vectors, Incidence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,984 participants (actual)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Collaborators
- S.C. Johnson & Son, Inc., Kenya Medical Research Institute, Centers for Disease Control and Prevention, fhiClinical
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 9 Dec 2023 (actual)
- First posted
- 23 Feb 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.
Spatial repellents are chemical-based devices that when placed in a room, make that room non-conducive for mosquitoes. These tools can be used to help in the fight against vector borne diseases such as malaria and dengue. However, their efficacy in reducing mosquito biting and therefore malaria transmission has never been evaluated in Africa. This study will evaluate the efficacy of a spatial repellent in reducing mosquito biting on human beings and measure the impact any reduced biting will have on malaria transmission. The investigators will recruit and follow-up 5,984 children between 6 months and <10 years of age in Busia County to determine how many times they will be infected with malaria in villages where the investigators will have distributed spatial repellents and compare the rate of infection to villages where the investigators will not have distributed the repellent devices. Additionally, the investigators will measure whether the distribution of spatial repellents in one village will drive mosquitoes to their neighboring houses thereby increasing malaria transmission in those areas. The children participating in the study will be divided into 3 groups (cohorts). The first group will be followed up during the first 4 months before any intervention is distributed and the purpose here will be to determine that the villages are comparable. After this, the investigators will recruit the next group of participants and follow them up for 1 year and repeat this again for another year. During the follow-up, the children will be asked to come to the health facility where they will be tested for malaria using RDT or blood slide for microscopy. Every two weeks, a member of the study team will come to the participant's house and ask them if they had any history of fever. If the participants had fever, they will be tested for malaria. All children who turn out to be positive for malaria by RDT will be treated free of charge. At the same time, the investigators shall also perform mosquito collections to determine the impact of spatial repellents on the density of Anopheles mosquitoes.
Detailed description
Spatial repellents (SRs) have been widely used for the prevention of mosquito bites but their protective efficacy (PE) in reducing mosquito-borne diseases has never been evaluated in Africa. To address this knowledge gap, western Kenya was selected as a site to estimate the impact of a transfluthrin-based spatial repellent on malaria-related outcomes in Busia County, where baseline malaria transmission ranges from 2.5 to 4.1 new infections per person per year.
A total of 5,984 children between 6 months and <10 years of age will be enrolled in three separate cohorts (baseline, cohort 1 and cohort 2). A total of 2,040 children from among 60 clusters will be enrolled for a four-month baseline prior to placement of the SR intervention. After baseline, a total of 1,972 participants from among 58 clusters, will be enrolled into cohort 1 and followed for one year. Cohort 2, consisting of a total of 1,972 children, will be enrolled from among 58 clusters to provide a total of two years of follow up. Children who have been selected for inclusion in the baseline cohort will be eligible for selection to cohort 1 or 2 but not both.
Cohort 1 and Cohort 2 during intervention will be split into two groups, one to estimate the direct effect of the SR (total of 1,624 children, 812 per follow up year) and a second to estimate the degree of diversion (or mass effect) of mosquitoes and malaria transmission from persons protected by the SR to persons who are unprotected (total of 2,320 children, 1,160 per follow up year). All cohorts will be followed once every two weeks with finger prick blood samples taken once every 4 weeks to test for malaria or whenever a participant reports a recent (within 48 hours) history of fever.
The incidence of malaria in the baseline cohort will be used to validate underlying assumptions prior to intervention. The incidence of malaria in each cohort followed with intervention will be estimated and compared to determine the benefit of using an SR in an area with high, year-round transmission of malaria. Monthly collections of mosquitoes using CDC light traps will be conducted to determine if there are entomological correlates of SR efficacy that may be useful for the evaluation of new SR products. Quarterly human landing catches will be done to assess the behavioral effects of the SR. The primary hypothesis on PE against the first-time malaria infection will be estimated by comparing the hazard rates of first-time malaria infection between SR and placebo upon the completion of the study in the ITT population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| 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 (8 listed)
- Children aged 6 months to <10 years
- Hb > 5mg/dl
- Sleeps in cluster >90% of nights during any given month
- No plans for extended travel (>1month) outside of home during study
- Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the Trial
Key exclusion criteria (9 listed)
- Children < 6 months or ≥ 10 years
- Hb ≤ 5 mg/dL, or Hb < 6mg/dL with signs of clinical decompensation
- Sleeps in cluster <90% of nights during any given month
- Plans for extended travel (>1month) outside of home during study
- Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
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
First-time malaria infection in core zones during intervention period.
Time frame: 12 months
Measured by microscopy in children aged between 6 months to 10 years.
14 secondary outcomes
Overall new malaria infections in core zones during intervention period.
Time frame: 12 months
Overall new malaria infections in buffer zones during intervention period.
Time frame: 12 months
Parasite-species-specific first-time malaria infections in the core zones.
Time frame: 12 months
Parasite-species-specific overall malaria infections in the core zones.
Time frame: 12 months
The first-time malaria infections in buffer zones during intervention period.
Time frame: 12 months
The first time malaria infections by two age groups (≤ 59 months old; 5 years to 10 years old).
Time frame: 12 months
Overall malaria infections by two age groups (≤ 59 months old; 5 years to 10 years old).
Time frame: 12 months
Anopheline-human contact (indoor and outdoor) using human biting rate (HBR) as an indicator for all anophelines and by anopheline species.
Time frame: 12 months
Anopheline parity rate as an indicator of population age structure for all anophelines and by anopheline species.
Time frame: 12 months
Anopheline infectivity using sporozoite rate as an indicator for all anophelines and by anopheline species.
Time frame: 12 months
Anopheline infectivity using EIR as an indicator for all anophelines and by anopheline species.
Time frame: 12 months
CDC-light trap indoor density for all anophelines and by anopheline species.
Time frame: 12 months
Insecticide resistance.
Time frame: 28 months
Adverse Events and Serious Adverse Events.
Time frame: 28 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 15 Apr 2024.
- Background: PubMed 21976557Hamel MJ, Adazu K, Obor D, Sewe M, Vulule J, Williamson JM, Slutsker L, Feikin DR, Laserson KF. A reversal in reductions of child mortality in western Kenya, 2003-2009. Am J Trop Med Hyg. 2011 Oct;85(4):597-605. doi: 10.4269/ajtmh.2011.10-0678.
- Background: PubMed 21629783Zhou G, Afrane YA, Vardo-Zalik AM, Atieli H, Zhong D, Wamae P, Himeidan YE, Minakawa N, Githeko AK, Yan G. Changing patterns of malaria epidemiology between 2002 and 2010 in Western Kenya: the fall and rise of malaria. PLoS One. 2011;6(5):e20318. doi: 10.1371/journal.pone.0020318. Epub 2011 May 23.
- 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 22433128Ogoma SB, Ngonyani H, Simfukwe ET, Mseka A, Moore J, Killeen GF. Spatial repellency of transfluthrin-treated hessian strips against laboratory-reared Anopheles arabiensis mosquitoes in a semi-field tunnel cage. Parasit Vectors. 2012 Mar 20;5:54. doi: 10.1186/1756-3305-5-54.
- Background: PubMed 25485850Ogoma SB, Ngonyani H, Simfukwe ET, Mseka A, Moore J, Maia MF, Moore SJ, Lorenz LM. The mode of action of spatial repellents and their impact on vectorial capacity of Anopheles gambiae sensu stricto. PLoS One. 2014 Dec 8;9(12):e110433. doi: 10.1371/journal.pone.0110433. eCollection 2014.
- 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 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 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 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 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.
- Derived from this study: PubMed 39709979Ochomo EO, Gimnig JE, Awori Q, Abong'o B, Oria P, Ashitiba NK, Polo B, Moshi V, Otanga H, Adung'o F, Ouma EA, Outa S, Ramaita E, Levine R, Odongo W, Harvey SA, Monroe A, Hudson A, Sandberg B, Hendrickson J, Zhao X, Zhou R, Liu F, Achee NL, Grieco JP. Effect of a spatial repellent on malaria incidence in an area of western Kenya characterised by high malaria transmission, insecticide resistance, and universal coverage of insecticide treated nets (part of the AEGIS Consortium): a cluster-randomised, controlled trial. Lancet. 2025 Jan 11;405(10473):147-156. doi: 10.1016/S0140-6736(24)02253-0. Epub 2024 Dec 19.
- Derived from this study: PubMed 35382858Ochomo EO, Gimnig JE, Bhattarai A, Samuels AM, Kariuki S, Okello G, Abong'o B, Ouma EA, Kosgei J, Munga S, Njagi K, Odongo W, Liu F, Grieco JP, Achee NL. Evaluation of the protective efficacy of a spatial repellent to reduce malaria incidence in children in western Kenya compared to placebo: study protocol for a cluster-randomized double-blinded control trial (the AEGIS program). Trials. 2022 Apr 5;23(1):260. doi: 10.1186/s13063-022-06196-x.
- Individual participant dataSharing planned: Yes. Analytical data 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
Eric Ochomo, Ph.D. principal investigator
Kenya Medical Research Institute
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 Kenya.
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 8 inclusion and 9 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 15 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 Kenya. 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?
First-time malaria infection in core zones during intervention period. (time frame: 12 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 NCT04766879, which also lists 12 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 15 Apr 2024.