NCT02045069

Efficacy and Safety of Ivermectin Against Dengue Infection

A Phase II/III, Randomized, Placebo Controlled Trial of Efficacy and Safety of Ivermectin in Children and Adult Patients With Dengue Infection

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Dengue Fever

Interventions

Type	Name	Description
DRUG	2 days Ivermectin	200-400 µg/kg once daily for 2 days and placebo once daily at D3
DRUG	3 days Ivermectin	200 -400 µg/kg once daily for 3 days
DRUG	Placebo	Placebo once daily for 3 days

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-02-01
• Completion: 2016-03-01
• First posted: 2014-01-24
• Last updated: 2015-11-02

Locations

1 site across 1 country: Thailand