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Interceptor® long-lasting insecticidal net: phase III evaluation over three years of household use and calibration with Phase II experimental hut outcomes
BACKGROUND: Long-lasting insecticidal nets (LN) are an effective tool for malaria prevention. The World Health Organization Pesticide Evaluation Scheme has established evaluation criteria to facilitate registration for public use. A household randomised trial was conducted in Tanzania according to W...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4831182/ https://www.ncbi.nlm.nih.gov/pubmed/27075874 http://dx.doi.org/10.1186/s13071-016-1490-9 |
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author | Tungu, Patrick Kirby, Matthew Malima, Robert Kisinza, William Magesa, Stephen Maxwell, Caroline Batengana, Benard Pigeon, Olivier Rowland, Mark |
author_facet | Tungu, Patrick Kirby, Matthew Malima, Robert Kisinza, William Magesa, Stephen Maxwell, Caroline Batengana, Benard Pigeon, Olivier Rowland, Mark |
author_sort | Tungu, Patrick |
collection | PubMed |
description | BACKGROUND: Long-lasting insecticidal nets (LN) are an effective tool for malaria prevention. The World Health Organization Pesticide Evaluation Scheme has established evaluation criteria to facilitate registration for public use. A household randomised trial was conducted in Tanzania according to WHOPES Phase III procedures to evaluate the alpha-cypermethrin coated Interceptor® LN (BASF) over three years’ use. Outcomes were calibrated against results of Phase II experimental hut trials. METHODS: Interceptor LN (200 mg/m(2) alpha-cypermethrin) and conventionally treated nets CTN (40 mg/m(2) alpha-cypermethrin) were randomly distributed to 934 households. At 6-monthly intervals, household surveys recorded net use, durability, adverse effects, user acceptance and washing practices. Concurrently, 30 nets of each type were collected and tested for knock-down and kill of Anopheles gambiae mosquitoes in cone and tunnel bioassays. Alpha-cypermethrin content of nets was assessed annually. RESULTS: At 12 months 97 % of Interceptor LN met the efficacy criteria by cone or tunnel test; this pass rate declined to 90 % at 24 months and 87 % at 36 months. In contrast only 63 % of CTN met the efficacy criteria at 12 months, 14 % at 24 months and 0 % at 36 months. The alpha-cypermethrin content at 36 months on Interceptor LN was 20 % (42 ± 13 mg/m(2)) of the initial content but on CTNs only 4 % (1.3 ± 1.6 mg/m(2)) remained. Interceptor LN was reported to be used year-round and washed 4.3 times/year. A few recalled facial tingling during the first days of use but this did not deter usage. The average number of holes at 36 months was 18, hole area per net was 229 cm(2) and hole index was 332. Insecticide content and cone bioefficacy of LN and CTN after 36 months’ use were similar to that of LN and CTN used in earlier Phase II hut trials, but while the 20 times washed LN tested in experimental huts gave adequate personal protection the 20 times washed CTN did not. CONCLUSIONS: More than 80 % Interceptor LN fulfilled the WHOPES Phase III criteria at 36 months and thus the LLIN was granted full WHO recommendation. Phase III outcomes at 36 months were anticipated by Phase II outcomes after 20 standardized washes. |
format | Online Article Text |
id | pubmed-4831182 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-48311822016-04-15 Interceptor® long-lasting insecticidal net: phase III evaluation over three years of household use and calibration with Phase II experimental hut outcomes Tungu, Patrick Kirby, Matthew Malima, Robert Kisinza, William Magesa, Stephen Maxwell, Caroline Batengana, Benard Pigeon, Olivier Rowland, Mark Parasit Vectors Research BACKGROUND: Long-lasting insecticidal nets (LN) are an effective tool for malaria prevention. The World Health Organization Pesticide Evaluation Scheme has established evaluation criteria to facilitate registration for public use. A household randomised trial was conducted in Tanzania according to WHOPES Phase III procedures to evaluate the alpha-cypermethrin coated Interceptor® LN (BASF) over three years’ use. Outcomes were calibrated against results of Phase II experimental hut trials. METHODS: Interceptor LN (200 mg/m(2) alpha-cypermethrin) and conventionally treated nets CTN (40 mg/m(2) alpha-cypermethrin) were randomly distributed to 934 households. At 6-monthly intervals, household surveys recorded net use, durability, adverse effects, user acceptance and washing practices. Concurrently, 30 nets of each type were collected and tested for knock-down and kill of Anopheles gambiae mosquitoes in cone and tunnel bioassays. Alpha-cypermethrin content of nets was assessed annually. RESULTS: At 12 months 97 % of Interceptor LN met the efficacy criteria by cone or tunnel test; this pass rate declined to 90 % at 24 months and 87 % at 36 months. In contrast only 63 % of CTN met the efficacy criteria at 12 months, 14 % at 24 months and 0 % at 36 months. The alpha-cypermethrin content at 36 months on Interceptor LN was 20 % (42 ± 13 mg/m(2)) of the initial content but on CTNs only 4 % (1.3 ± 1.6 mg/m(2)) remained. Interceptor LN was reported to be used year-round and washed 4.3 times/year. A few recalled facial tingling during the first days of use but this did not deter usage. The average number of holes at 36 months was 18, hole area per net was 229 cm(2) and hole index was 332. Insecticide content and cone bioefficacy of LN and CTN after 36 months’ use were similar to that of LN and CTN used in earlier Phase II hut trials, but while the 20 times washed LN tested in experimental huts gave adequate personal protection the 20 times washed CTN did not. CONCLUSIONS: More than 80 % Interceptor LN fulfilled the WHOPES Phase III criteria at 36 months and thus the LLIN was granted full WHO recommendation. Phase III outcomes at 36 months were anticipated by Phase II outcomes after 20 standardized washes. BioMed Central 2016-04-13 /pmc/articles/PMC4831182/ /pubmed/27075874 http://dx.doi.org/10.1186/s13071-016-1490-9 Text en © Tungu et al. 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Tungu, Patrick Kirby, Matthew Malima, Robert Kisinza, William Magesa, Stephen Maxwell, Caroline Batengana, Benard Pigeon, Olivier Rowland, Mark Interceptor® long-lasting insecticidal net: phase III evaluation over three years of household use and calibration with Phase II experimental hut outcomes |
title | Interceptor® long-lasting insecticidal net: phase III evaluation over three years of household use and calibration with Phase II experimental hut outcomes |
title_full | Interceptor® long-lasting insecticidal net: phase III evaluation over three years of household use and calibration with Phase II experimental hut outcomes |
title_fullStr | Interceptor® long-lasting insecticidal net: phase III evaluation over three years of household use and calibration with Phase II experimental hut outcomes |
title_full_unstemmed | Interceptor® long-lasting insecticidal net: phase III evaluation over three years of household use and calibration with Phase II experimental hut outcomes |
title_short | Interceptor® long-lasting insecticidal net: phase III evaluation over three years of household use and calibration with Phase II experimental hut outcomes |
title_sort | interceptor® long-lasting insecticidal net: phase iii evaluation over three years of household use and calibration with phase ii experimental hut outcomes |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4831182/ https://www.ncbi.nlm.nih.gov/pubmed/27075874 http://dx.doi.org/10.1186/s13071-016-1490-9 |
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