Efficacy and Safety of Ivermectin Against Dengue Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of High-dose Ivermectin for Reducing Malaria Transmission: A Dose Finding Study

NCT02511353

Malaria

COMPLETED PHASE2

Effectiveness Evaluation of a Dengue Self-monitoring System

NCT05688748

Dengue

COMPLETED NA

Combating Dengue With Innovative, Paradigm-shift-Strategies: Early Dengue Surveillance in Adult Aedes Mosquitoes

NCT03799237

Dengue

UNKNOWN NA

Ivermectin vs Combined Hydroxychloroquine and Antiretroviral Drugs (ART) Among Asymptomatic COVID-19 Infection

NCT04435587

Asymptomatic Infections SARS-CoV2 Infection

UNKNOWN PHASE4

Malaria Vaccine Safety and Immunogenicity Study in Healthy Adults

NCT02992119

Malaria Vaccine

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dengue Fever

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2 days Ivermectin

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

Group Type EXPERIMENTAL

2 days Ivermectin

Intervention Type DRUG

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

3 days Ivermectin

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

Group Type EXPERIMENTAL

3 days Ivermectin

Intervention Type DRUG

200 -400 µg/kg once daily for 3 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo once daily for 3 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

2 days Ivermectin

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

Intervention Type DRUG

3 days Ivermectin

200 -400 µg/kg once daily for 3 days

Intervention Type DRUG

Placebo

Placebo once daily for 3 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mectizan Ivomec Stromectol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Panisadee Avirutnan, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Division of Dengue Hemorrhagic Fever Research Department of Research and Development, Faculty of Medicine Siriraj Hospital Mahidol University, Bangkok 10700, THAILAND