NCT03432442

Pharmacokinetics and Pharmacodynamics of Ivermectin in Pediatric Dengue Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 1 Year – 15 Years
• Healthy volunteers: Not accepted

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

Detailed 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: 1. First interim analysis: After the completion of the last volunteer of the group with body weight \>30 kg receiving ivermectin 400 μg/kg every 24 hours for a total of three times (i.e. the sixth volunteer). 2. Second interim analysis: After the completion of the last volunteer of the group with body weight \>30 kg receiving ivermectin 600 μg/kg every 24 hours for a total of three times (i.e. the twelfth volunteer). 3. Third interim analysis: After the completion of the last volunteer of the group with body weight 15 to 30 kg receiving ivermectin 400 μg/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

Conditions

• Dengue Hemorrhagic Fever

Interventions

Type	Name	Description
DRUG	Ivermectin	Ivermectin once every 24 hours for three administrations

Timeline

• Start date: 2018-09-04
• Primary completion: 2020-09-22
• Completion: 2020-09-22
• First posted: 2018-02-14
• Last updated: 2021-02-24

Locations

1 site across 1 country: Thailand