NCT03432442: PKIDEN

Pharmacokinetics and Pharmacodynamics of Ivermectin in Pediatric Dengue Patients

Completed Phase 2 Last updated 24 February 2021

What this trial tests

Phase 2 trial testing Ivermectin in Dengue Hemorrhagic Fever in 24 participants. Completed in 22 September 2020.

Timeline

4 September 2018

Primary endpoint
22 September 2020

22 September 2020

Quick facts

Lead sponsor	Mahidol University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	4 September 2018
Primary completion	22 September 2020
Estimated completion	22 September 2020
Sites	1 location across Thailand

Drugs / interventions tested

• Ivermectin (ivermectin) — full drug profile →

Conditions studied

• Dengue Hemorrhagic Fever — all drugs for Dengue Hemorrhagic Fever →

Sponsor

Mahidol University

Who can join

Adults 1 to 15, any sex, with Dengue Hemorrhagic Fever. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current and Promising Antivirals Against Chikungunya Virus.
   Hucke FIL, Bugert JJ. · · 2020 · cited 41× · PMID 33384981 · DOI 10.3389/fpubh.2020.618624
2. Iminosugars: A host-targeted approach to combat Flaviviridae infections.
   Evans DeWald L, Starr C, Butters T, Treston A, et al · · 2020 · cited 31× · PMID 32768411 · DOI 10.1016/j.antiviral.2020.104881
3. Inhibition of Human Adenovirus Replication by the Importin α/β1 Nuclear Import Inhibitor Ivermectin.
   King CR, Tessier TM, Dodge MJ, Weinberg JB, et al · · 2020 · cited 31× · PMID 32641484 · DOI 10.1128/jvi.00710-20
4. Finding a chink in the armor: Update, limitations, and challenges toward successful antivirals against flaviviruses.
   Komarasamy TV, Adnan NAA, James W, Balasubramaniam VR. · · 2022 · cited 17× · PMID 35482672 · DOI 10.1371/journal.pntd.0010291
5. Immortalized stem cell-derived hepatocyte-like cells: An alternative model for studying dengue pathogenesis and therapy.
   Kongmanas K, Punyadee N, Wasuworawong K, Songjaeng A, et al · · 2020 · cited 16× · PMID 33216752 · DOI 10.1371/journal.pntd.0008835
6. A Comprehensive Review of the Development and Therapeutic Use of Antivirals in Flavivirus Infection.
   Tripathi A, Chauhan S, Khasa R. · · 2025 · cited 14× · PMID 39861863 · DOI 10.3390/v17010074
7. The pipeline for drugs for control and elimination of neglected tropical diseases: 2. Oral anti-infective drugs and drug combinations for off-label use.
   Pfarr KM, Krome AK, Al-Obaidi I, Batchelor H, et al · · 2023 · cited 10× · PMID 37907954 · DOI 10.1186/s13071-023-05909-8
8. Vector-Transmitted Flaviviruses: An Antiviral Molecules Overview.
   Diani E, Lagni A, Lotti V, Tonon E, et al · · 2023 · cited 10× · PMID 37894085 · DOI 10.3390/microorganisms11102427