A Phase 2 interventional study of Ivermectin in Dengue Hemorrhagic Fever, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 1 Year to 15 Years. Per ClinicalTrials.gov, last updated 2021-02-24.
Sponsored by Mahidol University · Phase 2, Interventional, and Treatment
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
The research team has planned to conduct three interim analyses for safety and one final report. The interim analyses will be conducted as follows:
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
65 studies on the registry are indexed under Severe Dengue; 5 are open to participants now.
This study's enrollment of 24 is below the median of 170 across 52 interventional studies indexed under Severe Dengue.
Browse Severe Dengue studies →Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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:
Having developed or showed the following laboratory values, warning signs or signs of severe dengue including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Volunteers weighed \> 30 kg receiving 400 µg of ivermectin per 1 kg of body weight
Drug: Ivermectin
Volunteers weighed 15 to 30 kg receiving 400 µg of ivermectin per 1 kg of body weight
Drug: Ivermectin
Volunteers weighed \> 30 kg receiving 600 µg of ivermectin per 1 kg of body weight
Drug: Ivermectin
Volunteers weighed 15 to 30 kg receiving 600 µg of ivermectin per 1 kg of body weight
Drug: Ivermectin
Ivermectin once every 24 hours for three administrations
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).
Time frame: 7 days
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.
Time frame: 7 days
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.
Time frame: 7 days
Viremia clearance
Time between the first drug administration and the point of specimen collection at which viral load becomes undetectable
Time frame: 7 days
NS1 antigenemia clearance
Time between the first drug administration and the point of specimen collection at which NS1 antigen becomes undetectable
Time frame: 7 days
Occurrences of adverse events
The number of volunteers with any adverse events by the total number of volunteers in the treatment group
Time frame: 7 days
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.
Time frame: 7 days
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2018 to primary completion in Sep 2020, 24 months.
Of 13 phase 2 interventional studies under Severe Dengue, half reached primary completion within 24 months of starting (the median); a quarter within 20 and three quarters within 47. This study's 24 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ivermectin