Dataset Information

Efficacy and Safety of a Single Dose versus a Multiple Dose Regimen of Mebendazole against Hookworm Infections in Children: A Randomised, Double-blind Trial.

ABSTRACT: Background:Single-dose mebendazole is widely used in preventive chemotherapy against the soil-transmitted helminths (STHs) Ascaris lumbricoides, hookworm and Trichuris trichiura, yet it shows limited efficacy against hookworm and T. trichiura infections. The use of adapted treatment regimens might provide a strategy to control and eliminate STH infections in STH-persistent settings. We evaluated the safety and efficacy of the multiple dose mebendazole regimen (3?days 100?mg bid) versus a single dose of 500?mg mebendazole in a setting with high STH prevalence and high drug pressure. Methods:This randomised, double-blind clinical trial took place in a primary school on Pemba Island, Tanzania, in school-aged children (6-12?years). Using a computer random number generator (block size 10), hookworm-positive children were randomly assigned (1:1) to either a single or multiple dose regimen of mebendazole by an independent statistician. Two stool samples were collected at baseline and follow-up (18 to 22?days after treatment) for Kato-Katz analysis. The primary outcome was cure rate (CR) against hookworm. Secondary outcomes were egg reduction rate (ERR) against hookworm, CRs and ERRs against A. lumbricoides and T. trichiura, and tolerability assessed 3, 24 and 48?h post-treatment. Participants, investigators, caregivers, outcome assessors and the trial statistician were blinded. This trial is registered with ClinicalTrials.gov, number NCT03245398. Findings:93 children were assigned to each treatment arm. 185 children completed treatment and provided follow-up stool samples. CR against hookworm was significantly higher in the multiple dose (98%) than in the single dose arm (13%, OR 389.1, 95% CI 95.2 to 2885.7%, p?

SUBMITTER: Palmeirim MS

PROVIDER: S-EPMC6537524 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Efficacy and Safety of a Single Dose <i>versus</i> a Multiple Dose Regimen of Mebendazole against Hookworm Infections in Children: A Randomised, Double-blind Trial.

Palmeirim Marta S MS Ame Shaali M SM Ali Said M SM Hattendorf Jan J Keiser Jennifer J

EClinicalMedicine 20180711

<h4>Background</h4>Single-dose mebendazole is widely used in preventive chemotherapy against the soil-transmitted helminths (STHs) <i>Ascaris lumbricoides</i>, hookworm and <i>Trichuris trichiura</i>, yet it shows limited efficacy against hookworm and <i>T. trichiura</i> infections. The use of adapted treatment regimens might provide a strategy to control and eliminate STH infections in STH-persistent settings. We evaluated the safety and efficacy of the multiple dose mebendazole regimen (3 days ...[more]

PMID: 31193620

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Dataset Information

Efficacy and Safety of a Single Dose versus a Multiple Dose Regimen of Mebendazole against Hookworm Infections in Children: A Randomised, Double-blind Trial.

Publications

Efficacy and Safety of a Single Dose <i>versus</i> a Multiple Dose Regimen of Mebendazole against Hookworm Infections in Children: A Randomised, Double-blind Trial.

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