Author:
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1.
WHO, 2006. Preventive Chemotherapy in Human Helminthiasis—Coordinated Use of Anthelminthic Drugs in Control Interventions: A Manual for Health Professionals and Programme Managers. Geneva, Switzerland: World Health Organization.
-
2.
WHO, 2005. Deworming for Health and Development. Geneva, Switzerland: World Health Organization.
-
3.
Albonico M, Allen H, Chitsulo L, Engels D, Gabrielli A-F, Savioli L, 2008. Controlling soil-transmitted helminthiasis in pre-school-age children through preventive chemotherapy. PLoS Negl Trop Dis 2: e126.
-
4.
Keiser J, Utzinger J, 2008. Efficacy of current drugs against soil-transmitted helminth infections: systematic review and meta-analysis. JAMA 299: 1937–1948.
-
5.
WHO, 2002. Report of the WHO Informal Consultation on the Use of Praziquantel during Pregnancy/Lactation and Albendazole/Mebendazole in Children Under 24 Months. WHO/CDS/CPE/PVC. Geneva, Switzerland: World Health Organization.
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6.
Urbani C, Albonico M, 2003. Anthelminthic drug safety and drug administration in the control of soil-transmitted helminthiasis in community campaigns. Acta Trop 86: 215–221.
-
7.
Montresor A, Stoltzfus RJ, Albonico M, Tielsch JM, Rice AL, Chwaya HM, Savioli L, 2002. Is the exclusion of children under 24 months from anthelmintic treatment justifiable? Trans R Soc Trop Med Hyg 96: 197–199.
-
8.
Awasthi S, Pande VK, 2001. Six-monthly de-worming in infants to study effects on growth. Indian J Pediatr 68: 823–827.
-
9.
Awasthi S, Peto R, Pande VK, Fletcher RH, Read S, Bundy DA, 2008. Effects of deworming on malnourished preschool children in India: an open-labelled, cluster-randomized trial. PLoS Negl Trop Dis 2: e223.
-
10.
Ndibazza J, Mpairwe H, Webb EL, Mawa PA, Nampijja M, Muhangi L, Kihembo M, Lule SA, Rutebarika D, Apule B, Akello F, Akurut H, Oduru G, Naniima P, Kizito D, Kizza M, Kizindo R, Tweyongere R, Alcock KJ, Muwanga M, Elliott AM, 2012. Impact of anthelminthic treatment in pregnancy and childhood on immunisations, infections and eczema in childhood: a randomised controlled trial. PLoS One 7: e50325.
-
11.
Awasthi S, Peto R, Read S, Richards SM, Pande V, Bundy D, DEVTA (Deworming and Enhanced Vitamin A) Team, 2013. Population deworming every 6 months with albendazole in 1 million pre-school children in north India: DEVTA, a cluster-randomised trial. Lancet 381: 1478–1486.
-
12.
WHO, 2015. Soil transmitted helminthiases: number of children treated in 2014. Wkly Epidemiol Rec 90: 705–711.
-
13.
Joseph SA, Casapia M, Blouin B, Maheu-Giroux M, Rahme E, Gyorkos TW, 2014. Risk factors associated with malnutrition in one-year-old children living in the Peruvian Amazon. PLoS Negl Trop Dis 8: e3369.
-
14.
Joseph SA, Casapia M, Montresor A, Rahme E, Ward BJ, Marquis GS, Pezo L, Blouin B, Maheu-Giroux M, Gyorkos TW, 2015. The effect of deworming on growth in one-year-old children living in a soil-transmitted helminth-endemic area of Peru: a randomized controlled trial. PLoS Negl Trop Dis 9: e0004020.
-
15.
Joseph SA, Casapía M, Lazarte F, Rahme E, Pezo L, Blouin B, Gyorkos TW, 2015. The effect of deworming on early childhood development in Peru: a randomized controlled trial. SSM Popul Health 1: 32–39.
-
16.
Edwards G, Breckenridge AM, 1988. Clinical pharmacokinetics of anthelmintic drugs. Clin Pharmacokinet 15: 67–93.
-
17.
Stoltzfus RJ, Chway HM, Montresor A, Tielsch JM, Jape JK, Albonico M, Savioli L, 2004. Low dose daily iron supplementation improves iron status and appetite but not anemia, whereas quarterly anthelminthic treatment improves growth, appetite and anemia in Zanzibari preschool children. J Nutr 134: 348–356.
-
18.
Montresor A, Awasthi S, Crompton DWT, 2003. Use of benzimidazoles in children younger than 24 months for the treatment of soil-transmitted helminthiasis. Acta Trop 86: 223–232.
-
19.
WHO, 2002. Prevention and Control of Schistosomiasis and Soil-Transmitted Helminthiasis. Report of a WHO Expert Committee, Technical Report Series, No. 912. Geneva, Switzerland: World Health Organization.
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20.
INEI, 2015. Peru Encuesta Demografica y de Salud Familiar—ENDES 2014. Lima, Peru: Instituto Nacional de Estadistica e Informatica.
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WHO/UNICEF, 2010. Sources and Prices of Selected Medicines for Children: Including Therapeutic Food, Dietary Vitamin and Mineral Supplementation, 2nd edition. Geneva, Switzerland: World Health Organization.
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Adverse Events from a Randomized, Multi-Arm, Placebo-Controlled Trial of Mebendazole in Children 12–24 Months of Age
Serene A. Joseph
Serene A. Joseph
Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Québec, Canada.
Division of Clinical Epidemiology, Research Institute of the McGill University Health Centre, Montréal, Québec, Canada.
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Division of Clinical Epidemiology, Research Institute of the McGill University Health Centre, Montréal, Québec, Canada.
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Antonio Montresor
Antonio Montresor
Department of Control of Neglected Tropical Diseases, World Health Organization, Geneva, Switzerland.
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Martín Casapía
Martín Casapía
Asociación Civil Selva Amazónica, Iquitos, Peru.
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Lidsky Pezo
Lidsky Pezo
Asociación Civil Selva Amazónica, Iquitos, Peru.
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Theresa W. Gyorkos
Theresa W. Gyorkos
Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Québec, Canada.
Division of Clinical Epidemiology, Research Institute of the McGill University Health Centre, Montréal, Québec, Canada.
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Division of Clinical Epidemiology, Research Institute of the McGill University Health Centre, Montréal, Québec, Canada.
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Large-scale deworming interventions, using anthelminthic drugs, are recommended in areas where the prevalence of soil-transmitted helminth infection is high. Anthelminthic safety has been established primarily in school-age children. Our objective was to provide evidence on adverse events from anthelminthic use in early childhood. A randomized multi-arm, placebo-controlled trial of mebendazole, administered at different times and frequencies, was conducted in children 12 months of age living in Iquitos, Peru. Children were followed up to 24 months of age. The association between mebendazole administration and the occurrence of a serious or minor adverse event was determined using logistic regression. There was a total of 1,686 administrations of mebendazole and 1,676 administrations of placebo to 1,760 children. Eighteen serious adverse events (i.e., 11 deaths and seven hospitalizations) and 31 minor adverse events were reported. There was no association between mebendazole and the occurrence of a serious adverse event (odds ratio [OR] = 1.21; 95% confidence interval [CI] = 0.47, 3.09) or a minor adverse event (OR = 0.84; 95% CI = 0.41, 1.72). Results from our trial support evidence of safety in administering mebendazole during early childhood. These results support World Health Organization deworming policy and the scaling up of interventions to reach children as of 12 months of age in endemic areas.
Author Notes
Financial support: This study was supported by the Thrasher Research Fund, the Canadian Institutes of Health Research (MOP-110969; Vanier Canada Graduate Scholarship; Michael Smith Foreign Study Supplement; Planning and Dissemination Grant), the Fonds de Recherche du Québec, Santé, and the Research Institute of the McGill University Health Centre.
Authors' addresses: Serene A. Joseph and Theresa W. Gyorkos, Division of Clinical Epidemiology, McGill University Health Centre, Montreal, Quebec, Canada, E-mails: serene.joseph@mail.mcgill.ca and theresa.gyorkos@mcgill.ca. Antonio Montresor, Department of Control of Neglected Tropical Diseases, World Health Organization, Geneva, Switzerland, E-mail: montresora@who.int. Martín Casapía and Lidsky Pezo, Asociación Civil Selva Amazónica, Iquitos, Peru, E-mails: mcasapia@acsaperu.org and lpezo@acsaperu.org.
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
WHO, 2006. Preventive Chemotherapy in Human Helminthiasis—Coordinated Use of Anthelminthic Drugs in Control Interventions: A Manual for Health Professionals and Programme Managers. Geneva, Switzerland: World Health Organization.
-
2.
WHO, 2005. Deworming for Health and Development. Geneva, Switzerland: World Health Organization.
-
3.
Albonico M, Allen H, Chitsulo L, Engels D, Gabrielli A-F, Savioli L, 2008. Controlling soil-transmitted helminthiasis in pre-school-age children through preventive chemotherapy. PLoS Negl Trop Dis 2: e126.
-
4.
Keiser J, Utzinger J, 2008. Efficacy of current drugs against soil-transmitted helminth infections: systematic review and meta-analysis. JAMA 299: 1937–1948.
-
5.
WHO, 2002. Report of the WHO Informal Consultation on the Use of Praziquantel during Pregnancy/Lactation and Albendazole/Mebendazole in Children Under 24 Months. WHO/CDS/CPE/PVC. Geneva, Switzerland: World Health Organization.
-
6.
Urbani C, Albonico M, 2003. Anthelminthic drug safety and drug administration in the control of soil-transmitted helminthiasis in community campaigns. Acta Trop 86: 215–221.
-
7.
Montresor A, Stoltzfus RJ, Albonico M, Tielsch JM, Rice AL, Chwaya HM, Savioli L, 2002. Is the exclusion of children under 24 months from anthelmintic treatment justifiable? Trans R Soc Trop Med Hyg 96: 197–199.
-
8.
Awasthi S, Pande VK, 2001. Six-monthly de-worming in infants to study effects on growth. Indian J Pediatr 68: 823–827.
-
9.
Awasthi S, Peto R, Pande VK, Fletcher RH, Read S, Bundy DA, 2008. Effects of deworming on malnourished preschool children in India: an open-labelled, cluster-randomized trial. PLoS Negl Trop Dis 2: e223.
-
10.
Ndibazza J, Mpairwe H, Webb EL, Mawa PA, Nampijja M, Muhangi L, Kihembo M, Lule SA, Rutebarika D, Apule B, Akello F, Akurut H, Oduru G, Naniima P, Kizito D, Kizza M, Kizindo R, Tweyongere R, Alcock KJ, Muwanga M, Elliott AM, 2012. Impact of anthelminthic treatment in pregnancy and childhood on immunisations, infections and eczema in childhood: a randomised controlled trial. PLoS One 7: e50325.
-
11.
Awasthi S, Peto R, Read S, Richards SM, Pande V, Bundy D, DEVTA (Deworming and Enhanced Vitamin A) Team, 2013. Population deworming every 6 months with albendazole in 1 million pre-school children in north India: DEVTA, a cluster-randomised trial. Lancet 381: 1478–1486.
-
12.
WHO, 2015. Soil transmitted helminthiases: number of children treated in 2014. Wkly Epidemiol Rec 90: 705–711.
-
13.
Joseph SA, Casapia M, Blouin B, Maheu-Giroux M, Rahme E, Gyorkos TW, 2014. Risk factors associated with malnutrition in one-year-old children living in the Peruvian Amazon. PLoS Negl Trop Dis 8: e3369.
-
14.
Joseph SA, Casapia M, Montresor A, Rahme E, Ward BJ, Marquis GS, Pezo L, Blouin B, Maheu-Giroux M, Gyorkos TW, 2015. The effect of deworming on growth in one-year-old children living in a soil-transmitted helminth-endemic area of Peru: a randomized controlled trial. PLoS Negl Trop Dis 9: e0004020.
-
15.
Joseph SA, Casapía M, Lazarte F, Rahme E, Pezo L, Blouin B, Gyorkos TW, 2015. The effect of deworming on early childhood development in Peru: a randomized controlled trial. SSM Popul Health 1: 32–39.
-
16.
Edwards G, Breckenridge AM, 1988. Clinical pharmacokinetics of anthelmintic drugs. Clin Pharmacokinet 15: 67–93.
-
17.
Stoltzfus RJ, Chway HM, Montresor A, Tielsch JM, Jape JK, Albonico M, Savioli L, 2004. Low dose daily iron supplementation improves iron status and appetite but not anemia, whereas quarterly anthelminthic treatment improves growth, appetite and anemia in Zanzibari preschool children. J Nutr 134: 348–356.
-
18.
Montresor A, Awasthi S, Crompton DWT, 2003. Use of benzimidazoles in children younger than 24 months for the treatment of soil-transmitted helminthiasis. Acta Trop 86: 223–232.
-
19.
WHO, 2002. Prevention and Control of Schistosomiasis and Soil-Transmitted Helminthiasis. Report of a WHO Expert Committee, Technical Report Series, No. 912. Geneva, Switzerland: World Health Organization.
-
20.
INEI, 2015. Peru Encuesta Demografica y de Salud Familiar—ENDES 2014. Lima, Peru: Instituto Nacional de Estadistica e Informatica.
-
21.
WHO/UNICEF, 2010. Sources and Prices of Selected Medicines for Children: Including Therapeutic Food, Dietary Vitamin and Mineral Supplementation, 2nd edition. Geneva, Switzerland: World Health Organization.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 21 | 21 | 9 |
| Full Text Views | 321 | 77 | 0 |
| PDF Downloads | 103 | 19 | 0 |