Clinical Trial: Efficacy and Safety of Ivermectin Against Dengue Infection
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase II/III, Randomized, Placebo Controlled Trial of Efficacy and Safety of Ivermectin in Children and Adult Patients With Dengue Infection
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: Mahidol University
Current Primary Outcome: Time 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. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Mahidol University
Dates:
Date Received: January 13, 2014
Date Started: February 2014
Date Completion: March 2016
Last Updated: October 29, 2015
Last Verified: October 2015