Permethrin-Treated Baby Wraps for the Prevention of Malaria.
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| Title: | Permethrin-Treated Baby Wraps for the Prevention of Malaria. |
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| Authors: | Boyce RM; Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill.; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill.; Carolina Population Center, University of North Carolina at Chapel Hill, Chapel Hill., Shook-Sa BE; Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill., Ndizeye R; Department of Community Health, Faculty of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda., Baguma E; Department of Community Health, Faculty of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda., Giandomenico D; Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill., Cassidy CA; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill., Eshun S; Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill., Siedner MJ; Massachusetts General Hospital, Boston.; Harvard Medical School, Boston., Staedke SG; Department of Vector Biology, Liverpool School of Tropical Medicine, Liverpool, United Kingdom., Ntaro M; Department of Community Health, Faculty of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda., Juliano JJ; Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill.; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill., Reyes R; Division of Hospital Medicine, UNC School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill., Mulogo EM; Department of Community Health, Faculty of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda. |
| Source: | The New England journal of medicine [N Engl J Med] 2025 Oct 09; Vol. 393 (14), pp. 1399-1408. Date of Electronic Publication: 2025 Sep 24. |
| Publication Type: | Journal Article; Randomized Controlled Trial |
| Language: | English |
| Journal Info: | Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1533-4406 (Electronic) Linking ISSN: 00284793 NLM ISO Abbreviation: N Engl J Med Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Boston, Massachusetts Medical Society. |
| MeSH Terms: | Insect Repellents*/adverse effects , Malaria*/diagnosis , Malaria*/epidemiology , Malaria*/prevention & control , Permethrin*/adverse effects, Adult ; Female ; Humans ; Infant ; Male ; Young Adult ; Double-Blind Method ; Incidence ; Insecticide-Treated Bednets ; Uganda/epidemiology ; Follow-Up Studies ; Exanthema/chemically induced ; Exanthema/epidemiology |
| Abstract: | Background: Malaria remains a major cause of childhood death in sub-Saharan Africa. We leveraged the traditional practice of mothers carrying children on their backs in cloth wraps to assess whether treating the wraps with an insect repellent might provide a layer of protection against malaria. Methods: In a double-blind, randomized, placebo-controlled trial conducted in Uganda, we enrolled adult women with a child who was 6 to 18 months of age. The mother-child pairs were randomly assigned in a 1:1 ratio to use permethrin-treated wraps (intervention group) or sham-treated wraps (control group). The wraps underwent retreatment every 4 weeks. All the participants received a new, pyrethroid-only long-lasting insecticide-treated bed net. The participants visited the trial clinics every 2 weeks for 24 weeks and made unscheduled visits in the case of febrile illness in the children. The primary outcome was clinical malaria in the children, as defined by fever and a positive malaria rapid diagnostic test. Results: From June 2022 through April 2024, a total of 419 mother-child pairs were screened, and 400 underwent randomization; 200 pairs were assigned to the intervention group and 200 to the control group. Clinic attendance was high (5194 of 5200 planned visits [99.9%] were attended), and no participants were lost to follow-up. The incidence rate of clinical malaria was 0.73 cases per 100 person-weeks (95% confidence interval [CI], 0.51 to 1.02) in the intervention group and 2.14 cases per 100 person-weeks (95% CI, 1.73 to 2.62) in the control group (incidence rate ratio, 0.34; 95% CI, 0.23 to 0.51; P<0.001). Rash was reported more often in the intervention group than in the control group (8.5% vs. 6.0% of participants). Conclusions: Among mother-child pairs who had access to bed nets, maternal use of permethrin-treated baby wraps significantly reduced the incidence of clinical malaria in the children. (Funded by the Doris Duke Foundation and others; ClinicalTrials.gov number, NCT05391230.). (Copyright © 2025 Massachusetts Medical Society.) |
| References: | N Engl J Med. 2012 Dec 13;367(24):2284-95. (PMID: 23136909) Am J Prev Med. 2014 May;46(5):473-80. (PMID: 24745637) Malar J. 2016 Oct 4;15(1):496. (PMID: 27716244) Clin Infect Dis. 1995 Sep;21(3):599-602. (PMID: 8527550) J Infect Dis. 2016 Nov 1;214(9):1403-1410. (PMID: 27534686) Parasitol Res. 2017 Feb;116(2):677-684. (PMID: 27942961) Ann Intern Med. 2010 Jun 1;152(11):726-32. (PMID: 20335313) PLoS One. 2023 Apr 27;18(4):e0284322. (PMID: 37104305) J Biomed Inform. 2009 Apr;42(2):377-81. (PMID: 18929686) Malar J. 2021 Jul 5;20(1):304. (PMID: 34225756) BMC Med. 2020 Feb 25;18(1):47. (PMID: 32098634) Pediatrics. 2008 Jul;122(1):e92-9. (PMID: 18541616) Malar J. 2022 Feb 23;21(1):63. (PMID: 35197060) Am J Perinatol. 2005 Feb;22(2):87-90. (PMID: 15731987) Int J Epidemiol. 2013 Feb;42(1):235-47. (PMID: 23396849) Lancet. 2024 Feb 10;403(10426):533-544. (PMID: 38310910) N Engl J Med. 2011 Nov 17;365(20):1863-75. (PMID: 22007715) Malar J. 2006 Jul 27;5:63. (PMID: 16872529) Trans R Soc Trop Med Hyg. 1999 Sep-Oct;93(5):465-72. (PMID: 10696399) Lancet Infect Dis. 2018 Jun;18(6):640-649. (PMID: 29650424) Parasit Vectors. 2019 Mar 12;12(1):94. (PMID: 30867018) Malar J. 2019 Dec 27;18(1):445. (PMID: 31881898) |
| Grant Information: | UM1 TR004406 United States TR NCATS NIH HHS; T32AI070114 United States NH NIH HHS; K24 AI134990 United States AI NIAID NIH HHS; K01AI182506 United States NH NIH HHS; UM1TR004406 United States TR NCATS NIH HHS; K24AI134990 United States NH NIH HHS; T32 AI070114 United States AI NIAID NIH HHS; K24 HL166024 United States HL NHLBI NIH HHS; K24HL166024 United States NH NIH HHS; K01 AI182506 United States AI NIAID NIH HHS; 24971 United States DDCF Doris Duke Charitable Foundation; K01AI182506 United States NH NIH HHS; K24AI134990 United States NH NIH HHS; K24HL166024 United States NH NIH HHS; T32AI070114 United States NH NIH HHS; UM1TR004406 United States TR NCATS NIH HHS |
| Molecular Sequence: | ClinicalTrials.gov NCT05391230 |
| Substance Nomenclature: | 0 (Insect Repellents) 509F88P9SZ (Permethrin) |
| Entry Date(s): | Date Created: 20250924 Date Completed: 20251008 Latest Revision: 20251114 |
| Update Code: | 20251114 |
| PubMed Central ID: | PMC12462887 |
| DOI: | 10.1056/NEJMoa2501628 |
| PMID: | 40991921 |
| Database: | MEDLINE |
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Nájsť tento článok vo Web of Science | Abstract: | Background: Malaria remains a major cause of childhood death in sub-Saharan Africa. We leveraged the traditional practice of mothers carrying children on their backs in cloth wraps to assess whether treating the wraps with an insect repellent might provide a layer of protection against malaria.<br />Methods: In a double-blind, randomized, placebo-controlled trial conducted in Uganda, we enrolled adult women with a child who was 6 to 18 months of age. The mother-child pairs were randomly assigned in a 1:1 ratio to use permethrin-treated wraps (intervention group) or sham-treated wraps (control group). The wraps underwent retreatment every 4 weeks. All the participants received a new, pyrethroid-only long-lasting insecticide-treated bed net. The participants visited the trial clinics every 2 weeks for 24 weeks and made unscheduled visits in the case of febrile illness in the children. The primary outcome was clinical malaria in the children, as defined by fever and a positive malaria rapid diagnostic test.<br />Results: From June 2022 through April 2024, a total of 419 mother-child pairs were screened, and 400 underwent randomization; 200 pairs were assigned to the intervention group and 200 to the control group. Clinic attendance was high (5194 of 5200 planned visits [99.9%] were attended), and no participants were lost to follow-up. The incidence rate of clinical malaria was 0.73 cases per 100 person-weeks (95% confidence interval [CI], 0.51 to 1.02) in the intervention group and 2.14 cases per 100 person-weeks (95% CI, 1.73 to 2.62) in the control group (incidence rate ratio, 0.34; 95% CI, 0.23 to 0.51; P<0.001). Rash was reported more often in the intervention group than in the control group (8.5% vs. 6.0% of participants).<br />Conclusions: Among mother-child pairs who had access to bed nets, maternal use of permethrin-treated baby wraps significantly reduced the incidence of clinical malaria in the children. (Funded by the Doris Duke Foundation and others; ClinicalTrials.gov number, NCT05391230.).<br /> (Copyright © 2025 Massachusetts Medical Society.) |
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| ISSN: | 1533-4406 |
| DOI: | 10.1056/NEJMoa2501628 |