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.
Am J Trop Med Hyg
; 97(6): 1851-1856, 2017 Dec.
Article
em En
| MEDLINE
| ID: mdl-29016336
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.
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Ascaríase
/
Tricuríase
/
Mebendazol
/
Antinematódeos
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article