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Efficacy and safety of a single-dose mebendazole 500 mg chewable, rapidly-disintegrating tablet for Ascaris Lumbricoides and Trichuris Trichiura infection treatment in pediatric patients : a double-blind, randomized, placebo-controlled, phase 3 study

Silber, Steven A. and Diro, Ermias and Workneh, Netsanet and Mekonnen, Zeleke and Levecke, Bruno and Steinmann, Peter and Umulisa, Irenee and Alemu, Hailemaryam and Baeten, Benny and Engelen, Marc and Hu, Peter and Friedman, Andrew and Baseman, Alan and Mrus, Joseph. (2017) Efficacy and safety of a single-dose mebendazole 500 mg chewable, rapidly-disintegrating tablet for Ascaris Lumbricoides and Trichuris Trichiura infection treatment in pediatric patients : a double-blind, randomized, placebo-controlled, phase 3 study. American journal of tropical medicine and hygiene, 97 (6). pp. 1851-1856.

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Official URL: https://edoc.unibas.ch/63215/

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Abstract

This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of a new chewable, rapidly-disintegrating mebendazole (MBZ) 500 mg tablet for Ascaris lumbricoides and Trichuris trichiura infection treatment. Pediatric patients (1-15 years; N = 295; from Ethiopia and Rwanda) excreting A. lumbricoides and/or T. trichiura eggs were enrolled. The study had a screening phase (3 days), a double-blind treatment phase (DBP, 19 days), and an open-label phase (OLP, 7 days). Patients received MBZ or placebo on day 1 of DBP and open-label MBZ on day 19 ± 2 after stool sample collection. Cure rates (primary endpoint), defined as species-specific egg count of 0 at the end of DBP, were significantly higher in the MBZ group than placebo for A. lumbricoides (83.7% [72/86; 95% CI: 74.2%; 90.8%] versus 11.1% [9/81; 95% CI: 5.2%; 20.1%], P < 0.001) and for T. trichiura (33.9% [42/124; 95% CI: 25.6%; 42.9%] versus 7.6% [9/119; 95% CI: 3.5%; 13.9%], P < 0.001). Egg reduction rates (secondary endpoint) were significantly higher in the MBZ group than placebo for A. lumbricoides (97.9% [95% CI: 94.4; 99.9] versus 19.2% [95% CI: -5.9; 41.5]; P < 0.001) and T. trichiura (59.7% [95% CI: 33.9; 78.8] versus 10.5% [95% CI: -16.8; 32.9]; P = 0.003). Treatment-emergent adverse events (TEAEs) in MBZ group occurred in 6.3% (9/144) of patients during DBP and 2.5% (7/278) during OLP. No deaths, serious TEAEs, or TEAEs leading to discontinuations were reported. A 500 mg chewable MBZ tablet was more efficacious than placebo for the treatment of A. lumbricoides and T. trichiura infections in pediatric patients, and no safety concerns were identified.
Faculties and Departments:09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Swiss Centre for International Health > Health Systems Support (Prytherch)
UniBasel Contributors:Steinmann, Peter
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Williams and Wilkins
ISSN:0002-9637
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:03 Jul 2018 07:45
Deposited On:03 Jul 2018 07:45

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