Spatial Repellents for the Prevention of Malaria in Kenya

NCT04766879 | Completed DMC

• 1 other identifier: 19-08-5506
• Study Type: interventional
• Target: 5,984
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Malaria

Keywords

Malaria; Spatial Repellent; Transfluthrin; Vector-borne diseases; Mosquito vectors; Incidence

Outcome Measures

Primary Outcomes (1)

• First-time malaria infection in core zones during intervention period.

  Measured by microscopy in children aged between 6 months to 10 years.

  12 months

Secondary Outcomes (14)

• Overall new malaria infections in core zones during intervention period.

  12 months

• Overall new malaria infections in buffer zones during intervention period.

  12 months

• Parasite-species-specific first-time malaria infections in the core zones.

  12 months

• Parasite-species-specific overall malaria infections in the core zones.

  12 months

• The first-time malaria infections in buffer zones during intervention period.

  12 months

Study Arms (2)

Spatial Repellent

EXPERIMENTAL

Transfluthrin

Device: Transfluthrin

Placebo

PLACEBO COMPARATOR

Inert ingredients

Device: Placebo

Interventions

Transfluthrin DEVICE

Passive emanator with formulated transfluthrin

Spatial Repellent

Placebo DEVICE

Passive emanator with formulated inert ingredients

Placebo

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of Notre Dame: lead
• S.C. Johnson & Son, Inc.: collaborator
• Kenya Medical Research Institute: collaborator
• Centers for Disease Control and Prevention: collaborator
• fhiClinical: collaborator

Study Sites (2)

Centers for Disease Control and Prevention

Busia, Busia County, Kenya

Location

Kenya Medical Research Institute (KEMRI)

Busia, Busia County, Kenya

Location

Related Publications (12)

• 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.

  PMID: 21976557 BACKGROUND

• Zhou 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.

  PMID: 21629783 BACKGROUND

• 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.

  PMID: 23216844 BACKGROUND

• Ogoma 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.

  PMID: 22433128 BACKGROUND

• Ogoma 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.

  PMID: 25485850 BACKGROUND

• 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.

  PMID: 22583679 BACKGROUND

• 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.

  PMID: 17536367 BACKGROUND

• 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.

  PMID: 18939693 BACKGROUND

• 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.

  PMID: 25311699 BACKGROUND

• 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.

  PMID: 24885993 BACKGROUND

• Ochomo 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.

  PMID: 39709979 DERIVED

• Ochomo 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.

  PMID: 35382858 DERIVED

MeSH Terms

Conditions

Malaria; Vector Borne Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• John P Grieco, Ph.D.

  University of Notre Dame

  STUDY DIRECTOR

• Eric Ochomo, Ph.D.

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 23, 2021
• Study Start: March 2, 2021
• Primary Completion: October 23, 2023
• Study Completion: December 9, 2023
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data and supporting information will be made available 12 months following completion of data analysis and will remain open access in the public domain.
• Access Criteria: Open-access repository distributed under the terms of the Creative Commons Attribution (CC-BY) License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Locations

KE (2)