NCT02045069

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

January 13, 2014

Last Update Submit

October 29, 2015

Conditions

Dengue Fever

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (2)

  • 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.

  • Time of subsidence of fever

    From date of randomization until fever subsides

Study Arms (3)

2 days Ivermectin

EXPERIMENTAL

Ivermectin 200 - 400 µg/kg once daily for 2 days

Drug: 2 days Ivermectin

3 days Ivermectin

EXPERIMENTAL

Ivermectin 200-400 µg/kg once daily for 3 days

Drug: 3 days Ivermectin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

2 days IvermectinDRUG

200-400 µg/kg once daily for 2 days and placebo once daily at D3

Also known as: Mectizan, Ivomec, Stromectol
2 days Ivermectin
3 days IvermectinDRUG

200 -400 µg/kg once daily for 3 days

3 days Ivermectin
PlaceboDRUG

Placebo once daily for 3 days

Placebo

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

RECRUITING

Related Publications (1)

  • Ooi EE. Repurposing Ivermectin as an Anti-dengue Drug. Clin Infect Dis. 2021 May 18;72(10):e594-e595. doi: 10.1093/cid/ciaa1341. No abstract available.

    PMID: 33124646DERIVED

MeSH Terms

Conditions

Dengue

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yupin Supputamonkol, MD.

CONTACT

6681-754-5573ysuputtamongkol@gmail.com

Panisadee Avirutnan, MD, PhD.

CONTACT

6681-895-0019panisadee.avi@mahidol.ac.th

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 24, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

November 2, 2015

Record last verified: 2015-10

Locations

TH(1)