Efficacy and Safety of Ivermectin Against Dengue Infection

Phase 2

• Conditions: Dengue Fever
• Interventions: Drug: 2 days Ivermectin; Drug: 3 days Ivermectin; Drug: Placebo

• Registration Number: NCT02045069
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Study Start: 2014-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-11-01
• Primary Completion: 2016-02
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 days Ivermectin	2 days Ivermectin	Ivermectin 200 - 400 µg/kg once daily for 2 days
3 days Ivermectin	3 days Ivermectin	Ivermectin 200-400 µg/kg once daily for 3 days
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand