Pharmacokinetics and Pharmacodynamics of Ivermectin in Pediatric Dengue Patients

Summary

Participation Requirements

Description

The research team has planned to conduct three interim analyses for safety and one final report. The interim analyses will be conducted as follows: First interim analysis: After the completion of the last volunteer of the group with body weight >30 kg receiving ivermectin 400 ?g/kg every 24 hours fo...

The research team has planned to conduct three interim analyses for safety and one final report. The interim analyses will be conducted as follows: First interim analysis: After the completion of the last volunteer of the group with body weight >30 kg receiving ivermectin 400 ?g/kg every 24 hours for a total of three times (i.e. the sixth volunteer). Second interim analysis: After the completion of the last volunteer of the group with body weight >30 kg receiving ivermectin 600 ?g/kg every 24 hours for a total of three times (i.e. the twelfth volunteer). Third interim analysis: After the completion of the last volunteer of the group with body weight 15 to 30 kg receiving ivermectin 400 ?g/kg every 24 hours for a total of three times (i.e. the twelfth volunteer). The results of each interim analyses will be submitted to DSMB to determine whether the study is safe to be conducted in the next group of volunteers. Additionally, the results of interim analyses and the safety assessments from DSMB will be submitted to all ECs

Tracking Information