Efficacy and Safety of Ivermectin Against Dengue Infection

October 29, 2015 updated by: Mahidol University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital, Mahidol University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo once daily for 3 days
Experimental: 2 days Ivermectin
Ivermectin 200 - 400 µg/kg once daily for 2 days
Drug: 2 days Ivermectin
200-400 µg/kg once daily for 2 days and placebo once daily at D3
Other Names:
  • Stromectol
  • Mectizan
  • Ivomec
Experimental: 3 days Ivermectin
Ivermectin 200-400 µg/kg once daily for 3 days
Drug: 3 days Ivermectin
200 -400 µg/kg once daily for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to resolution of viremia
Time Frame: Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.
Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to clearance of NS1 antigen
Time Frame: Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.
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
Time Frame: From date of randomization until fever subsides
From date of randomization until fever subsides

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Ministry of Health, Thailand

Investigators

  • Principal Investigator: Panisadee Avirutnan, MD, PhD., Division of Dengue Hemorrhagic Fever Research Department of Research and Development, Faculty of Medicine Siriraj Hospital Mahidol University, Bangkok 10700, THAILAND

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

January 13, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 29, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESIDEN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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