Efficacy and Safety of Ivermectin Against Dengue Infection

Mahidol University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Dengue Fever

Treatments: Drug: 2 days Ivermectin; Drug: 3 days Ivermectin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02045069

ESIDEN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 3 patient groups, including a placebo group

2 days Ivermectin

Experimental group

Description:

Ivermectin 200 - 400 µg/kg once daily for 2 days

Treatment:

Drug: 2 days Ivermectin

3 days Ivermectin

Experimental group

Description:

Ivermectin 200-400 µg/kg once daily for 3 days

Treatment:

Drug: 3 days Ivermectin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo