Status and phase
Conditions
Treatments
About
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
Full 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:
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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
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
Primary purpose
Allocation
Interventional model
Masking
24 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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