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Efficacy and Safety of Ivermectin Against Dengue Infection

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Mahidol University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02045069
First Posted: January 24, 2014
Last Update Posted: November 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, Thailand
Information provided by (Responsible Party):
Mahidol University
  Purpose
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.

Condition Intervention Phase
Dengue Fever Drug: 2 days Ivermectin Drug: 3 days Ivermectin Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II/III, Randomized, Placebo Controlled Trial of Efficacy and Safety of Ivermectin in Children and Adult Patients With Dengue Infection

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • 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. ]
  • Time of subsidence of fever [ Time Frame: From date of randomization until fever subsides ]

Estimated Enrollment: 360
Study Start Date: February 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Mectizan
  • Ivomec
  • Stromectol
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
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo once daily for 3 days

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045069


Contacts
Contact: Yupin Supputamonkol, MD. 6681-754-5573 ysuputtamongkol@gmail.com
Contact: Panisadee Avirutnan, MD, PhD. 6681-895-0019 panisadee.avi@mahidol.ac.th

Locations
Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Nasikarn Angkasekwinai, MD    66818708766    nasikarn@gmail.com   
Sponsors and Collaborators
Mahidol University
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
  More Information

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02045069     History of Changes
Other Study ID Numbers: ESIDEN
First Submitted: January 13, 2014
First Posted: January 24, 2014
Last Update Posted: November 2, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Ivermectin
Antiparasitic Agents
Anti-Infective Agents