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Efficacy and Safety of Ivermectin Against Dengue Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Mahidol University
Sponsor:
Collaborator:
Ministry of Health, Thailand
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT02045069
First received: January 13, 2014
Last updated: October 29, 2015
Last verified: October 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
  • Time of subsidence of fever [ Time Frame: From date of randomization until fever subsides ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: January 13, 2014
Last Updated: October 29, 2015
Health Authority: Thailand: Ministry of Public Health

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

ClinicalTrials.gov processed this record on December 09, 2016