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Safety of a New Chewable Formulation of Mebendazole for Preventive Chemotherapy Interventions to Treat Young Children in Countries with Moderate-to-High Prevalence of Soil Transmitted Helminth Infections
Joint Authors
Friedman, Andrew J.
Albonico, Marco
Ali, Said M.
Source
Issue
Vol. 2012, Issue 2012 (31 Dec. 2012), pp.1-7, 7 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2012-12-24
Country of Publication
Egypt
No. of Pages
7
Main Subjects
Abstract EN
The primary objective was to evaluate the safety and tolerability of the new chewable formulation of mebendazole to treat soil-transmitted helminth (STH) infections in children ≤10 years old with the goal of using this formulation in preventive chemotherapy programs and expand treatment to young children who are unable to swallow solid tablets.
In this open-label, single-arm, phase 3 study conducted at Pemba Island, Zanzibar, Tanzania, children aged 2 to 10 years (median age: 4 years) were administered a single dose of the mebendazole 500 mg chewable tablet.
Safety was assessed 30 minutes after dose and 3 days later.
Of the 390 (98%) children who completed the study, 195 (55%) had ≥1 STH infection and 157 (45%) had no infection at baseline.
The most common STH infections were Trichuris trichiura (51%), hookworm (16%), and Ascaris lumbricoides (7%).
Treatment-emergent adverse events (TEAEs) were experienced by 11% of children.
There was no difference in the percentage of children experiencing TEAEs between the age strata of 2–5 years and 6–10 years.
Diarrhea was reported only in children aged 2–5 years.
No correlation was observed between the type or percentage of AEs and presence or severity of infection.
A single dose of mebendazole 500 mg chewable tablet was safe and well tolerated in children aged 2 to 10 years.
American Psychological Association (APA)
Friedman, Andrew J.& Ali, Said M.& Albonico, Marco. 2012. Safety of a New Chewable Formulation of Mebendazole for Preventive Chemotherapy Interventions to Treat Young Children in Countries with Moderate-to-High Prevalence of Soil Transmitted Helminth Infections. Journal of Tropical Medicine،Vol. 2012, no. 2012, pp.1-7.
https://search.emarefa.net/detail/BIM-483236
Modern Language Association (MLA)
Friedman, Andrew J.…[et al.]. Safety of a New Chewable Formulation of Mebendazole for Preventive Chemotherapy Interventions to Treat Young Children in Countries with Moderate-to-High Prevalence of Soil Transmitted Helminth Infections. Journal of Tropical Medicine No. 2012 (2012), pp.1-7.
https://search.emarefa.net/detail/BIM-483236
American Medical Association (AMA)
Friedman, Andrew J.& Ali, Said M.& Albonico, Marco. Safety of a New Chewable Formulation of Mebendazole for Preventive Chemotherapy Interventions to Treat Young Children in Countries with Moderate-to-High Prevalence of Soil Transmitted Helminth Infections. Journal of Tropical Medicine. 2012. Vol. 2012, no. 2012, pp.1-7.
https://search.emarefa.net/detail/BIM-483236
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-483236