Efficacy and Safety of Ivermectin Against Dengue Infection

• Status: Unknown status
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Collaborator: Ministry of Health, Thailand
• Treatments: Ivermectin

Criteria

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