Clinical trial NCT02045069: Efficacy and Safety of Ivermectin Against Dengue Infection
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Dengue Fever
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Thailand
First posted: 2014-01-24
Enrollment: 360
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Time to resolution of viremia
timeFrame: Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.
Secondary outcomes:
measure: Time to clearance of NS1 antigen
timeFrame: Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.
measure: Time of subsidence of fever
timeFrame: From date of randomization until fever subsides
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Division of Dengue Hemorrhagic Fever Research Department of Research and Development, Faculty of Medicine Siriraj Hospital Mahidol University, Bangkok 10700, THAILAND
name: Panisadee Avirutnan, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.