This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Ivermectin Against Dengue Infection

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.
 
ClinicalTrials.gov Identifier: NCT02045069
Recruitment Status : Unknown
Verified October 2015 by Mahidol University.
Recruitment status was:  Recruiting
First Posted : January 24, 2014
Last Update Posted : November 1, 2015
Sponsor:
Collaborator:
Ministry of Health, Thailand
Information provided by (Responsible Party):
Mahidol University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Dengue Fever Drug: 2 days Ivermectin Drug: 3 days Ivermectin Drug: Placebo Phase 2 Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
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
Study Start Date : February 2014
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever
Drug Information available for: Ivermectin

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. 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. ]
  2. Time of subsidence of fever [ Time Frame: From date of randomization until fever subsides ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location 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
Layout table for location information
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
Layout table for investigator information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02045069    
Other Study ID Numbers: ESIDEN
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: November 1, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Dengue
Infections
Mosquito-Borne Diseases
Vector Borne Diseases
Arbovirus Infections
Virus Diseases
Flavivirus Infections
 Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Ivermectin
Antiparasitic Agents
Anti-Infective Agents