Status:
COMPLETED
Pharmacokinetics and Pharmacodynamics of Ivermectin in Pediatric Dengue Patients
Lead Sponsor:
Mahidol University
Conditions:
Dengue Hemorrhagic Fever
Eligibility:
All Genders
1-15 years
Phase:
PHASE2
Brief 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 wit...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
September 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03432442
Start Date
September 4 2018
End Date
September 22 2020
Last Update
February 24 2021
Active Locations (1)
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1
Faculty of Tropical Medicine Siriraj Hospital
Bangkok Noi, Bangkok, Thailand, 10700