Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura

Summary

The study rationale is to provide evidence on effective doses of moxidectin and/or moxidectin-albendazole in adolescents (16-18 years old) infected with Trichuris trichiura. The study will take place on Pemba Island, Tanzania.

Timeline

Start

2018-07-03

Primary completion

2018-08-11

Completion

2018-08-11

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper The primary outcome was cure rate (CR) against T. trichiura, analyzed 13 to 20 days after treatment by quadruple Kato-Katz thick smears. PMID 31044235 ↗

paper CRs against T. trichiura were 43, 46, and 44% for 8, 16, and 24 mg of moxidectin alone, respectively; 60, 62, and 66% for the same moxidectin dosages plus 400 mg of albendazole, respectively; and 12% for placebo. PMID 31044235 ↗

Publications

• Keller L, Palmeirim MS, Ame SM, Ali SM, Puchkov M, Huwyler J, Hattendorf J, Keiser J. Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris trichiura in Adolescents: A Randomized Controlled Trial. Clin Infect Dis. 2020 Mar 3;70(6):1193-1201. doi: 10.1093/cid/ciz326.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Albendazole	Small molecule	400 mg	—
Subject	Moxidectin	Other / unclassified	8 mg	—
Subject	Moxidectin	Other / unclassified	16 mg	—
Subject	Moxidectin	Other / unclassified	24 mg	—

Indications