Efficacy and Safety of Ivermectin Against Dengue Infection

Dengue Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02045069
• Other study ID #: ESIDEN
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 13, 2014
• Last updated: October 29, 2015
• Start date: February 2014
• Est. completion date: March 2016

Study information

• Verified date: October 2015
• Source: Mahidol University
• Contact: Yupin Supputamonkol, MD.
• Phone: 6681-754-5573
• Email: ysuputtamongkol[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Dengue
• Dengue Fever

Intervention

Drug:
• 2 days Ivermectin
200-400 µg/kg once daily for 2 days and placebo once daily at D3
• 3 days Ivermectin
200 -400 µg/kg once daily for 3 days
• Placebo
Placebo once daily for 3 days

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Ministry of Health, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	Time of subsidence of fever		From date of randomization until fever subsides	No