Efficacy and Safety of IVM/ALB Co-administration

Summary

This study is a double-blind randomized clinical trial conducted with two settings in Africa and one in Asia, namely Côte d'Ivoire, Pemba (Zanzibar, Tanzania) and Lao PDR. This study aims at providing evidence on the efficacy and safety of co-administered albendazole and ivermectin versus albendazole monotherapy (standard of care) against whipworm (T. trichiura) infections in children and adults (6-60 years). The efficacy of the treatment and potential extended effects on follow-up prevalence will be determined 14-21 days, 6 months and 12 months post-treatment by collecting another two stool samples. The cure rate will be calculated as the percentage of egg-positive subjects at baseline who become egg-negative after treatment.

Timeline

Start

2018-09-09

Primary completion

2020-05-15

Completion

2020-07-15

Publications

• Welsche S, Schneeberger PHH, Hattendorf J, Sayasone S, Hurlimann E, Keiser J. Egg excretion patterns of soil-transmitted helminth infections in humans following albendazole-ivermectin and albendazole treatment. PLoS Negl Trop Dis. 2024 Mar 22;18(3):e0012073. doi: 10.1371/journal.pntd.0012073. eCollection 2024 Mar.
• Schneeberger PHH, Gueuning M, Welsche S, Hurlimann E, Dommann J, Haberli C, Frey JE, Sayasone S, Keiser J. Different gut microbial communities correlate with efficacy of albendazole-ivermectin against soil-transmitted helminthiases. Nat Commun. 2022 Feb 25;13(1):1063. doi: 10.1038/s41467-022-28658-1.
• Hurlimann E, Keller L, Patel C, Welsche S, Hattendorf J, Ali SM, Ame SM, Sayasone S, Coulibaly JT, Keiser J. Efficacy and safety of co-administered ivermectin and albendazole in school-aged children and adults infected with Trichuris trichiura in Cote d'Ivoire, Laos, and Pemba Island, Tanzania: a double-blind, parallel-group, phase 3, randomised controlled trial. Lancet Infect Dis. 2022 Jan;22(1):123-135. doi: 10.1016/S1473-3099(21)00421-7. Epub 2021 Nov 29.
• Keller L, Welsche S, Patel C, Sayasone S, Ali SM, Ame SM, Hattendorf J, Hurlimann E, Keiser J. Long-term outcomes of ivermectin-albendazole versus albendazole alone against soil-transmitted helminths: Results from randomized controlled trials in Lao PDR and Pemba Island, Tanzania. PLoS Negl Trop Dis. 2021 Jun 30;15(6):e0009561. doi: 10.1371/journal.pntd.0009561. eCollection 2021 Jun.
• Patel C, Hurlimann E, Keller L, Hattendorf J, Sayasone S, Ali SM, Ame SM, Coulibaly JT, Keiser J. Efficacy and safety of ivermectin and albendazole co-administration in school-aged children and adults infected with Trichuris trichiura: study protocol for a multi-country randomized controlled double-blind trial. BMC Infect Dis. 2019 Mar 18;19(1):262. doi: 10.1186/s12879-019-3882-x.

Drugs

Indications