At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Ascending Dosages of Albendazole Against T. Trichiura and Hookworm in Preschool- and School-aged Children and Adults: a Randomized Controlled Trial
In Brief
A Phase 2 clinical trial evaluating Albendazole and Placebo for Trichuriasis and Hookworm Infections. Completed, enrolled 700 participants across 1 site.
Detailed Summary
This study is a single-blind randomized clinical trial conducted in rural Côte d'Ivoire. This study aims at providing evidence on the dose-response of increasing oral albendazole dosages against whipworm (T. trichiura) and hookworm infections in preschoolers (2-5 years), school-aged children (6-12 years) and adults (≥ 21 years). The primary objective is to determine cure rates (primary end point, i.e. conversion from being egg positive pre-treatment to egg negative post-treatment). Secondary objectives involve the determination of egg reduction rates (the reduction in the number of excreted eggs from baseline (prior to treatment) to follow-up) and the assessment of safety of ascending dosages of albendazole (secondary end points). In addition, key pharmacokinetic parameters will be determined from blood samples collected with a micro-sampling device (secondary end point).
Study Details
Timeline
Interventions
Single dose of albendazole (200mg, dependent on treatment cohort)
Single dose of albendazole (400mg, dependent on treatment cohort)
Single dose of albendazole (600mg, dependent on treatment cohort)
Single dose of albendazole (800mg, dependent on treatment cohort)
Matching placebo tablets will be obtained from Fagron, Germany.