Pharmacokinetics and Pharmacodynamics of Ivermectin in Pediatric Dengue Patients

Summary

Design and Outcomes This research study is designed as open-label, sequential dose-escalating clinical trial. There will be two phases of enrollment. In the first phase, pediatric dengue patients with body weight greater than 30 kg will be recruited. The first six volunteers will be administered with 400 μg/kg every 24 hours for a total of three times. The last six volunteers will be administered with 600 μg/kg every 24 hours for a total of three times. In the second phase, pediatric dengue patients with body weight between 15 to 30 kg will be recruited. Similar to the first phase, the first six and the last six volunteers will be administered with 400 μg/kg and 600 μg/kg every 24 hours for a total of three times, respectively. A total of 24 volunteers will be recruited from Faculty of Medicine Siriraj hospitals

Timeline

Start

2018-09-04

Primary completion

2020-09-22

Completion

2020-09-22

Publications

• Kawuma AN, Ojara FW, Buzibye A, Castelnuovo B, Tabwenda JC, Kyeyune J, Turyahabwe C, Asiimwe SP, Magoola J, Wiesner L, Nakijoba R, Waitt C. Interim analysis, a tool to enhance efficiency of pharmacokinetic studies: Pharmacokinetics of rifampicin in lactating mother-infant pairs. CPT Pharmacometrics Syst Pharmacol. 2024 Nov;13(11):1915-1923. doi: 10.1002/psp4.13247. Epub 2024 Oct 2.
• Ding J, Mairiang D, Prayongkul D, Puttikhunt C, Noisakran S, Kaewjiw N, Songjaeng A, Prommool T, Tangthawornchaikul N, Angkasekwinai N, Suputtamongkol Y, Lapphra K, Chokephaibulkit K, White NJ, Avirutnan P, Tarning J. In-host modeling of dengue virus and non-structural protein 1 and the effects of ivermectin in patients with acute dengue fever. CPT Pharmacometrics Syst Pharmacol. 2024 Dec;13(12):2196-2209. doi: 10.1002/psp4.13233. Epub 2024 Sep 23.

Drugs

Indications