Efficacy and Safety of Ivermectin Against Dengue Infection

Condition(s) targeted: Dengue Fever

Intervention: 2 days Ivermectin (Drug); 3 days Ivermectin (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Not yet recruiting

Sponsored by: Mahidol University

Overall contact:
Yupin Supputamonkol, MD., Phone: 6681-754-5573, Email: ysuputtamongkol@gmail.com

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Time to resolution of viremia

Secondary outcome:

Time to clearance of NS1 antigen

Time of subsidence of fever

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.

Minimum age: 15 Years. Maximum age: N/A. Gender(s): Both.

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

Yupin Supputamonkol, MD., Phone: 6681-754-5573, Email: ysuputtamongkol@gmail.com

Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand; Not yet recruiting
Nasikarn Angkasekwinai, MD, Phone: 66818708766, Email: nasikarn@gmail.com

Starting date: February 2014
Last updated: January 22, 2014