Spatial Repellents for Malaria Control

NCT06122142 | Withdrawn DMC

• 1 other identifier: 23-05-7909
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of the study is to demonstrate and quantify the effectiveness of a spatial repellent (SR) product, in reducing malaria infection in humans under operational program conditions in a humanitarian assistance context. The design will be a cluster Randomized Control Trial (cRCT) representing an operational research study.

Conditions

Malaria

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Effectiveness of SR against malaria infection (both first-time and recurrent).

  Measured by rapid diagnostic tests in children aged between 6 months to 59 months.

  12 months

Secondary Outcomes (2)

• Cost-effectiveness of SR distribution.

  12 months

• Adverse Events and Serious Adverse Events.

  12 months

Study Arms (3)

Study personnel distribution channel

ACTIVE COMPARATOR

SR product will be delivered by paid study personnel.

Device: Transfluthrin - delivery by paid study personnel

Voucher distribution channel

EXPERIMENTAL

Voucher which will be used to redeem for SR product(s) on a monthly basis for each head of household.

Device: Transfluthrin - delivery by voucher system

Village health team distribution channel

EXPERIMENTAL

Village health teams will distribute SR products.

Device: Transfluthrin - delivery by village health teams

Interventions

Transfluthrin - delivery by paid study personnel DEVICE

Passive emanator with formulated transfluthrin, SR product will be delivered by paid study personnel

Study personnel distribution channel

Transfluthrin - delivery by voucher system DEVICE

Passive emanator with formulated transfluthrin, voucher which will be used to redeem for SR product(s) on a monthly basis for each head of household.

Voucher distribution channel

Transfluthrin - delivery by village health teams DEVICE

Passive emanator with formulated transfluthrin, village health teams will distribute SR products.

Village health team distribution channel

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children ≥ 6 months to ≤ 59 months
• Children ≥ 6 months to ≤ 59 months with Hb \> 7g/dL and no other serious illness
• Sleeps in cluster (i.e. study area) ≥ 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 form (ICF) signed by the parent(s) or guardian

You may not qualify if:

• Children \< 6 months and \> 59 months
• Children ≥ 6 months to ≤ 59 months with Hb ≤ 7g/dL with signs of other serious illness or Hb ≤ 7 g/dL with signs of clinical decompensation
• Sleeps in cluster (i.e. study area) \< 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 signed by the parent(s) or guardian

Sponsors & Collaborators

• University of Notre Dame: lead
• S.C. Johnson & Son, Inc.: collaborator
• Catholic Relief Services: collaborator
• Infectious Diseases Research Collaboration, Uganda: collaborator

Study Sites (2)

Catholic Relief Services

Kampala, Uganda

Location

Infectious Disease Research Collaboration

Kampala, Uganda

Location

Related Publications (12)

• 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

• Hamel MJ, Otieno P, Bayoh N, Kariuki S, Were V, Marwanga D, Laserson KF, Williamson J, Slutsker L, Gimnig J. The combination of indoor residual spraying and insecticide-treated nets provides added protection against malaria compared with insecticide-treated nets alone. Am J Trop Med Hyg. 2011 Dec;85(6):1080-6. doi: 10.4269/ajtmh.2011.10-0684.

  PMID: 22144448 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

• 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

• Morrison AC, Reiner RC Jr, Elson WH, Astete H, Guevara C, Del Aguila C, Bazan I, Siles C, Barrera P, Kawiecki AB, Barker CM, Vasquez GM, Escobedo-Vargas K, Flores-Mendoza C, Huaman AA, Leguia M, Silva ME, Jenkins SA, Campbell WR, Abente EJ, Hontz RD, Paz-Soldan VA, Grieco JP, Lobo NF, Scott TW, Achee NL. Efficacy of a spatial repellent for control of Aedes-borne virus transmission: A cluster-randomized trial in Iquitos, Peru. Proc Natl Acad Sci U S A. 2022 Jun 28;119(26):e2118283119. doi: 10.1073/pnas.2118283119. Epub 2022 Jun 23.

  PMID: 35737833 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, Asih PBS, Rozi IE, Permana DH, Nur Hidayati AP, Syahrani L, Zubaidah S, Sidik D, Bangs MJ, Bogh C, Liu F, Eugenio EC, Hendrickson J, Burton T, Baird JK, Collins F, Grieco JP, Lobo NF, Achee NL. Efficacy of a Spatial Repellent for Control of Malaria in Indonesia: A Cluster-Randomized Controlled Trial. Am J Trop Med Hyg. 2020 Jul;103(1):344-358. doi: 10.4269/ajtmh.19-0554. Epub 2020 May 14.

  PMID: 32431275 BACKGROUND

• The Republic of Uganda Ministry of Health. Annual Health Sector Performance Report Financial Year 2021/22. Ministry of Health, Uganda.

  BACKGROUND

• Uganda National Malaria Control Division (NMCD), Uganda Bureau of Statistics (UBOS), and ICF. 2019. 2018-19 Uganda Malaria Indicator Survey Atlas of Key Indicators. Kampala, Uganda, and Rockville, Maryland, USA: NMCD, UBOS, and ICF.

  BACKGROUND

• World Health Organization. Twelfth meeting of the WHO Vector Control Advisory Group. Geneva: World Health Organization; 2020.

  BACKGROUND

• Nakyaze E, Van Hulle S, Hembling J, Arinaitwe E, Mbodji M, Alwano MG, Lamwaka FC, Tukwasibwe S, Gonahasa S, Liu F, Grieco JP, Achee NL. Advancing spatial repellents for malaria control: effectiveness and cost-effectiveness of a spatial repellent under operational use in Northern Uganda-study protocol for a cluster randomized controlled trial. Trials. 2024 Aug 22;25(1):555. doi: 10.1186/s13063-024-08378-1.

  PMID: 39175062 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

• 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: October 27, 2023
• First Posted: November 8, 2023
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

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

UG (2)