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Pharmacokinetics and Pharmacodynamics of Ivermectin in Pediatric Dengue Patients

NCT03432442 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-02-24

No results posted yet for this study

Summary

Design and Outcomes This research study is designed as open-label, sequential dose-escalating clinical trial. There will be two phases of enrollment.

In the first phase, pediatric dengue patients with body weight greater than 30 kg will be recruited. The first six volunteers will be administered with 400 μg/kg every 24 hours for a total of three times. The last six volunteers will be administered with 600 μg/kg every 24 hours for a total of three times.

In the second phase, pediatric dengue patients with body weight between 15 to 30 kg will be recruited. Similar to the first phase, the first six and the last six volunteers will be administered with 400 μg/kg and 600 μg/kg every 24 hours for a total of three times, respectively.

A total of 24 volunteers will be recruited from Faculty of Medicine Siriraj hospitals

Conditions

  • Dengue Hemorrhagic Fever

Interventions

DRUG

Ivermectin

Ivermectin once every 24 hours for three administrations

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Panisadee Avirutnan, Assoc. Prof. · Siriraj Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-04
Primary Completion
2020-09-22
Completion
2020-09-22

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03432442 on ClinicalTrials.gov