Spatial Repellents for Vector Control

NCT04795648 | Completed DMC

• 1 other identifier: 20-10-6245
• Study Type: interventional
• Target: 1,911
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Malaria

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of first-time malaria infections during intervention period.

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

  24 months

Secondary Outcomes (12)

• Number of overall new malaria infections during intervention period.

  24 months

• Parasite-species-specific first-time malaria infections.

  24 months

• Parasite-species-specific overall malaria infections.

  24 months

• Number of first-time malaria infections by two age groups (≤ 59 months old; 5 years old to 10 years old).

  24 months

• Number of overall malaria infections by two age groups (≤ 59 months old; 5 years to 10 years old).

  24 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 ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Notre Dame: lead
• S.C. Johnson & Son, Inc.: collaborator
• fhiClinical: collaborator
• Malaria Research and Training Center, Bamako, Mali: collaborator
• Catholic Relief Services: collaborator

Study Sites (2)

Catholic Relief Services

Bamako, Mali

Location

Malaria Research and Training Center (MRTC), University of Bamako, Mali

Bamako, Mali

Location

Related Publications (11)

• 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

• 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.

  PMID: 26296644 BACKGROUND

• 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.

  PMID: 12752657 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

• 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

• 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.

  PMID: 26740098 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

• 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

• 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

• 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.

  PMID: 17255234 BACKGROUND

• 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.

  PMID: 35382856 DERIVED

Related Links

• 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

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

• Suzanne Van Hulle, M.H.S

  Catholic Relief Services

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The study design will be a prospective cluster Randomized Control Trial (cRCT)

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: July 8, 2021
• Primary Completion: March 2, 2024
• Study Completion: March 2, 2024
• Last Updated: April 2, 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

MA (2)