Dengue FeverPhase 2/3NCT02045069
Efficacy and Safety of Ivermectin Against Dengue Infection
A Phase 2/3 study testing 2 days Ivermectin and 3 days Ivermectin in people with Dengue Fever, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Dengue Fever
- What is being tested?
- 2 days Ivermectin and 3 days Ivermectin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2014to Mar 2016
- Phase
- Phase 2/3
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
Nasikarn Angkasekwinai, MD, 66818708766, nasikarn@gmail.com
About this study
Official title: A Phase II/III, Randomized, Placebo Controlled Trial of Efficacy and Safety of Ivermectin in Children and Adult Patients With Dengue Infection
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.
Read the 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.
- Conditions
- Dengue Fever
- Being tested
- 2 days Ivermectin, 3 days Ivermectin, Placebo
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 days IvermectinDrug
Also called Mectizan, Ivomec, Stromectol
200-400 µg/kg once daily for 2 days and placebo once daily at D3
3 days IvermectinDrug
200 -400 µg/kg once daily for 3 days
PlaceboDrug
Placebo once daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| 2 days Ivermectin | Experimental | Ivermectin 200 - 400 µg/kg once daily for 2 days Receives: Drug: 2 days Ivermectin |
| 3 days Ivermectin | Experimental | Ivermectin 200-400 µg/kg once daily for 3 days Receives: Drug: 3 days Ivermectin |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution of viremia
Measured: Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.
Secondary outcomes (2)
Time to clearance of NS1 antigen
Measured: Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.
Time of subsidence of fever
Measured: From date of randomization until fever subsides
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Responsible party
- Sponsor
- Investigators
- Panisadee Avirutnan, MD, PhD., Principal investigator, Division of Dengue Hemorrhagic Fever Research Department of Research and Development, Faculty of Medicine Siriraj Hospital Mahidol University, Bangkok 10700, THAILAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045069
- Sponsor's protocol ID
- ESIDEN
- Status last verified
- Oct 2015
- First submitted
- 13 Jan 2014
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 39356094Ding 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 39308445Ooi 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.
PubMed 33124646
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III, Randomized, Placebo Controlled Trial of Efficacy and Safety of Ivermectin in Children and Adult Patients With Dengue Infection
- ClinicalTrials.gov ID
- NCT02045069
- Acronym / sponsor ID
- ESIDEN
- Conditions
- Dengue Fever
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Study start
- Feb 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 days Ivermectin | Experimental | Drug: 2 days IvermectinIvermectin 200 - 400 µg/kg once daily for 2 days |
| 3 days Ivermectin | Experimental | Drug: 3 days IvermectinIvermectin 200-400 µg/kg once daily for 3 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 days IvermectinAlso: Mectizan, Ivomec, Stromectol200-400 µg/kg once daily for 2 days and placebo once daily at D3 | Drug | 2 days Ivermectin |
| 3 days Ivermectin200 -400 µg/kg once daily for 3 days | Drug | 3 days Ivermectin |
| PlaceboPlacebo once daily for 3 days | Drug | Placebo |
Primary outcome
Time to resolution of viremia
Time frame: Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.
2 secondary outcomes
Time to clearance of NS1 antigen
Time frame: Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.
Time of subsidence of fever
Time frame: From date of randomization until fever subsides
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
- Derived from this study: PubMed 39356094Kawuma 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.
- Derived from this study: PubMed 39308445Ding 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.
- Derived from this study: PubMed 33124646Ooi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panisadee Avirutnan, MD, PhD. principal investigator
Division of Dengue Hemorrhagic Fever Research Department of Research and Development, Faculty of Medicine Siriraj Hospital Mahidol University, Bangkok 10700, THAILAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 2 days Ivermectin and 3 days Ivermectin in people with Dengue 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Nov 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yupin Supputamonkol, MD. (6681-754-5573, ysuputtamongkol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to resolution of viremia (time frame: Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.). 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 NCT02045069, 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 2 Nov 2015.