Albendazole Dose Finding and Pharmacokinetics in Children and Adults
Status:
Completed
Trial end date:
2019-04-17
Target enrollment:
Participant gender:
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).
Phase:
Phase 2
Details
Lead Sponsor:
Jennifer Keiser
Collaborator:
Centre Suisse de Recherches Scientifiques en Cote d'Ivoire