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
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Ivermectin once every 24 hours for three administrations
Faculty of Tropical Medicine Siriraj Hospital
Bangkok Noi, Bangkok, Thailand
Pharmacokinetics of ivermectin in pediatric dengue patients
Blood samples will be collected, and ivermectin plasma concentrations will be measured with High Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS).
Time frame: 7 days
Pharmacodynamic effects of ivermectin on viral load in plasma of pediatric dengue patients
Blood samples will be collected, and viral load in plasma will be measured with quantitative RT-PCR.
Time frame: 7 days
Pharmacodynamic effects of ivermectin on NS1 antigen in plasma of pediatric dengue patients
Blood samples will be collected, and NS1 antigen in plasma will be measured with NS1-ELISA assay.
Time frame: 7 days
Viremia clearance
Time between the first drug administration and the point of specimen collection at which viral load becomes undetectable
Time frame: 7 days
NS1 antigenemia clearance
Time between the first drug administration and the point of specimen collection at which NS1 antigen becomes undetectable
Time frame: 7 days
Occurrences of adverse events
The number of volunteers with any adverse events by the total number of volunteers in the treatment group
Time frame: 7 days
Occurrences of abnormal laboratory result
The number of volunteers with any change of laboratory results from normal at baseline to abnormal during the study by the total number of volunteers in the treatment group.
Time frame: 7 days
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