Albendazole Dose Finding and Pharmacokinetics in Children and Adults

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).

Timeline

Start

2018-10-23

Primary completion

2019-04-17

Completion

2019-04-17

Publications

• Patel C, Coulibaly JT, Hofmann D, N'Gbesso Y, Hattendorf J, Keiser J. Efficacy and Safety of Albendazole in Hookworm-infected Preschool-aged Children, School-aged Children, and Adults in Cote d'Ivoire: A Phase 2 Randomized, Controlled Dose-finding Trial. Clin Infect Dis. 2021 Jul 15;73(2):e494-e502. doi: 10.1093/cid/ciaa989.
• Patel C, Coulibaly JT, Schulz JD, N'Gbesso Y, Hattendorf J, Keiser J. Efficacy and safety of ascending dosages of albendazole against Trichuris trichiura in preschool-aged children, school-aged children and adults: A multi-cohort randomized controlled trial. EClinicalMedicine. 2020 May 5;22:100335. doi: 10.1016/j.eclinm.2020.100335. eCollection 2020 May.

Drugs

Indications