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Dengue Hemorrhagic FeverPhase 2PKIDENNCT03432442

Pharmacokinetics and Pharmacodynamics of Ivermectin in Pediatric Dengue Patients

A Phase 2 study testing Ivermectin in people with Dengue Hemorrhagic Fever, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 15 years
Conditions the study is for
Dengue Hemorrhagic Fever
What is being tested?
Ivermectin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteThailand
Study dates
4 Sep 2018to 22 Sep 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Aged between 1-15 years 0 day
  • Weight is equal or greater than 15 kg
  • History or presence of acute fever within the last 72 hours diagnosed as acute dengue virus infection
  • Patients who are expected to be able to start the study drug within 72 hours of fever
  • Written informed consent to enroll in the study is obtained from parents or legal representatives and/or patients.
  • The test for dengue nonstructural protein 1 is positive, or PCR screening for viral genome is positive
  • Female patients with history of menarche need to have a negative result for urine pregnancy test, except during a menstrual period.

Who cannot join

  • Has significant underlying disease(s) that can affect the study outcome or the study participation may be harmful to patients with those underlying diseases including but not limited to:
  • Kidney disease
  • Thalassemia
  • congenital heart disease
  • epilepsy
  • cerebral palsy Other underlying diseases may result in exclusion depending on the judgement of investigator.
Show all 23Show fewer
  • Having developed or showed the following laboratory values, warning signs or signs of severe dengue including:
  • AST and/or ALT levels > 500 IU/L
  • Platelets count < 50,000 cells/mm3
  • Abdominal pain or tenderness
  • Persistent vomiting
  • Clinical fluid accumulation such as pleural effusion, ascites
  • Mucosal bleeding
  • Lethargy/restlessness
  • Liver enlargement >2 cm
  • Increase in Hct concurrent with rapid decrease in platelet count
  • Severe plasma leakage such as dengue shock syndrome, fluid accumulation with respiratory distress
  • Severe bleeding as evaluated by clinician
  • Severe organ involvement including but not limited to acute liver failure, altered level of consciousness (e.g. encephalopathy, encephalitis), seizure or other CNS unusual manifestation, acute renal failure, cardiomyopathy and other unusual manifestation
  • History of ivermectin allergy or receiving medications that increase gamma-aminobutyric acid (GABA) potentiating activity such as barbiturates, benzodiazepines, sodium oxybate, valproic acid, or receiving medications that prevent p-glycoprotein transport system such as amiodarone, carvedilol, clarithromycin, cyclosporine, erythromycin, itraconazole, ketoconazole, quinidine, ritonavir, tamoxifen, verapamil, amprenavir, clotrimazole, phenothiazines, rifampin, St. John's Wort etc.
  • Currently receiving immunosuppressive agents such as steroid (except topical steroid), chemotherapeutic agents or have discontinued these medications for less than a month
  • Having a history of receiving ivermectin within one month
  • Inability to ingest medications in a form of tablets as informed by patients and their parents or legal representatives

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Faculty of Tropical Medicine Siriraj Hospital

    Bangkok Noi, Bangkok, 10700

Other trials in Thailand

About this study

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.

Read more

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

Read the detailed description

The research team has planned to conduct three interim analyses for safety and one final report. The interim analyses will be conducted as follows:

  1. First interim analysis: After the completion of the last volunteer of the group with body weight >30 kg receiving ivermectin 400 μg/kg every 24 hours for a total of three times (i.e. the sixth volunteer).
  2. Second interim analysis: After the completion of the last volunteer of the group with body weight >30 kg receiving ivermectin 600 μg/kg every 24 hours for a total of three times (i.e. the twelfth volunteer).
  3. Third interim analysis: After the completion of the last volunteer of the group with body weight 15 to 30 kg receiving ivermectin 400 μg/kg every 24 hours for a total of three times (i.e. the twelfth volunteer).

The results of each interim analyses will be submitted to DSMB to determine whether the study is safe to be conducted in the next group of volunteers. Additionally, the results of interim analyses and the safety assessments from DSMB will be submitted to all ECs

Being tested
Ivermectin
Medical subject headings
Severe Dengue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IvermectinDrug

    Ivermectin once every 24 hours for three administrations

Study groups in NCT03432442
Study groupRoleWhat they receive
Group 1 (6 dengue patients)ExperimentalVolunteers weighed > 30 kg receiving 400 µg of ivermectin per 1 kg of body weight
Receives: Drug: Ivermectin
Group 2 (6 dengue patients)ExperimentalVolunteers weighed 15 to 30 kg receiving 400 µg of ivermectin per 1 kg of body weight
Receives: Drug: Ivermectin
Group 3 (6 dengue patients)ExperimentalVolunteers weighed > 30 kg receiving 600 µg of ivermectin per 1 kg of body weight
Receives: Drug: Ivermectin
Group 4 (6 dengue patients)ExperimentalVolunteers weighed 15 to 30 kg receiving 600 µg of ivermectin per 1 kg of body weight
Receives: Drug: Ivermectin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics of ivermectin in pediatric dengue patients

    Blood samples will be collected, and ivermectin plasma concentrations will be measured with High Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS).

    Measured: 7 days

Secondary outcomes (6)

  1. Pharmacodynamic effects of ivermectin on viral load in plasma of pediatric dengue patients

    Blood samples will be collected, and viral load in plasma will be measured with quantitative RT-PCR.

    Measured: 7 days

  2. Pharmacodynamic effects of ivermectin on NS1 antigen in plasma of pediatric dengue patients

    Blood samples will be collected, and NS1 antigen in plasma will be measured with NS1-ELISA assay.

    Measured: 7 days

  3. Viremia clearance

    Time between the first drug administration and the point of specimen collection at which viral load becomes undetectable

    Measured: 7 days

  4. NS1 antigenemia clearance

    Time between the first drug administration and the point of specimen collection at which NS1 antigen becomes undetectable

    Measured: 7 days

  5. Occurrences of adverse events

    The number of volunteers with any adverse events by the total number of volunteers in the treatment group

    Measured: 7 days

  6. Occurrences of abnormal laboratory result

    The number of volunteers with any change of laboratory results from normal at baseline to abnormal during the study by the total number of volunteers in the treatment group.

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2018
  2. Study start4 Sep 2018
  3. Primary completion22 Sep 2020
  4. Study completion22 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03432442
Sponsor's protocol ID
VIR17003
Acronym
PKIDEN
Status last verified
Feb 2021
First submitted
21 Dec 2017
Last updated
24 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lapphra K, Mairiang D, Tarning J, Prayongkul D, Puttikhunt C, Songjaeng A, Prommool T, Tangthawornchaikul N, Chokephaibulkit K, Avirutnan P. Repeated-Dose High-Dose Ivermectin Pharmacokinetics and Safety in Children with Acute Dengue. Paediatr Drugs. 2026 Sep 22. doi: 10.1007/s40272-026-00771-4. Online ahead of print.

    PubMed 42773329

  • Kawuma AN, Ojara FW, Buzibye A, Castelnuovo B, Tabwenda JC, Kyeyune J, Turyahabwe C, Asiimwe SP, Magoola J, Wiesner L, Nakijoba R, Waitt C. Interim analysis, a tool to enhance efficiency of pharmacokinetic studies: Pharmacokinetics of rifampicin in lactating mother-infant pairs. CPT Pharmacometrics Syst Pharmacol. 2024 Nov;13(11):1915-1923. doi: 10.1002/psp4.13247. Epub 2024 Oct 2.

    PubMed 39356094

  • Ding J, Mairiang D, Prayongkul D, Puttikhunt C, Noisakran S, Kaewjiw N, Songjaeng A, Prommool T, Tangthawornchaikul N, Angkasekwinai N, Suputtamongkol Y, Lapphra K, Chokephaibulkit K, White NJ, Avirutnan P, Tarning J. In-host modeling of dengue virus and non-structural protein 1 and the effects of ivermectin in patients with acute dengue fever. CPT Pharmacometrics Syst Pharmacol. 2024 Dec;13(12):2196-2209. doi: 10.1002/psp4.13233. Epub 2024 Sep 23.

    PubMed 39308445

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ivermectin in people with Dengue Hemorrhagic Fever, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics of ivermectin in pediatric dengue patients (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03432442, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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