This is a Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Ivermectin in Children and Adult patients with Dengue Infection.
Patients with confirmed dengue infection who meet all inclusion and exclusion criteria will be enrolled in the study and admitted in the hospital. Patients will be randomly assigned in a pre-specified ratio of 1:1:1 to one of the following study groups: ivermectin 200-400 µg/kg single daily dose for 2 days, ivermectin 200-400 µg/kg single daily dose for 3 days, or placebo. Tablets of ivermectin or placebo will be administered for 3 days. Clinical exam will be performed daily during hospitalization and blood samples will be collected for hematology, clinical chemistry, serology, viral load and quantitative nonstructural 1 (NS1) antigen. Safety assessment will be conducted during admission. Patients will be discharged one day after fever subsidence and will be asked to return 2 weeks after first dose of study medication for safety assessment and blood sampling.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
360
200-400 µg/kg once daily for 2 days and placebo once daily at D3
200 -400 µg/kg once daily for 3 days
Placebo once daily for 3 days
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, Thailand
RECRUITINGTime to resolution of viremia
Time frame: Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.
Time to clearance of NS1 antigen
Time frame: Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.
Time of subsidence of fever
Time frame: From date of randomization until fever subsides
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