Dengue Fever
Conditions
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 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.
Interventions
DRUG2 days Ivermectin
200-400 µg/kg once daily for 2 days and placebo once daily at D3
DRUG3 days Ivermectin
200 -400 µg/kg once daily for 3 days
DRUGPlacebo
Placebo once daily for 3 days
Sponsors
Ministry of Health, Thailand
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults ages of 15 or greater. * History or presence of fever (temperature \> 38°C) of ≤ 72 hr duration. * Clinical suspicion of dengue infection such as high fever without an evidence or suspected focus of infection on clinical examination. * Positive NS 1 strip assay
Exclusion criteria
* Clinically significant abnormal laboratory results which are deemed to be unassociated with dengue infection * Clinical evidence or a history of significant respiratory, metabolic, renal, hepatic, hematologic or chronic diseases * History of autoimmune, immune dysfunction disorder or taking warfarin * Clinical suspicion of any bacterial infection * Pregnancy and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to resolution of viremia | Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first. |
Secondary
| Measure | Time frame |
|---|---|
| Time to clearance of NS1 antigen | 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 | From date of randomization until fever subsides |
Countries
Thailand
Contacts
Primary ContactYupin Supputamonkol, MD.
Backup ContactPanisadee Avirutnan, MD, PhD.
Outcome results
None listed