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Sponsors and Collaborators: |
Duke University Pediatric Pharmacology Research Unit Network |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00797420 |
The purpose of this study is to investigate the pharmacokinetics and safety of a fluconazole loading dose in infants and toddlers.
Condition | Intervention | Phase |
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Candidiasis |
Drug: Fluconazole Loading Dose Drug: Fluconazole Loading Dose & High Dose |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study |
Official Title: | Pharmacokinetics of a Fluconazole Loading Dose in Infants and Toddlers |
Estimated Enrollment: | 48 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Loading Dose
Loading Dose
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Drug: Fluconazole Loading Dose
Single Fluconazole loading dose 25 mg/kg
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Loading & high dose
Loading dose & high dose Fluconazole
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Drug: Fluconazole Loading Dose & High Dose
Fluconazole loading dose 25 mg/kg, followed by fluconazole 12 mg/kg q24 hours for total of 5 days
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This is an open label study to investigative the pharmacokinetics and safety of a fluconazole loading dose in infants and toddlers < 2 years of age with suspected sepsis. There will be two treatment groups: single fluconazole loading dose 25 mg/kg; fluconazole loading dose 25mg/kg followed by 12 mg/kg daily for total of 5 days. There will be three age cohorts within each group: pre-term < 30 week EGA infants > 48 hours and < 31 days; > 30 weeks EGA infants > 48 hours and < 31 days; infants ≥ 31 days and < 2 years of age. The study requires administration of fluconazole over 1-5 days depending on treatment group followed by 1 week of safety monitoring. Six to eight 100 µL PK samples will be obtained over the 5 days of drug administration. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of empirical antifungal therapy), and information from the study may benefit a large number of other infants and toddlers with suspected or proven fungal sepsis. There is a data analysis plan.
Ages Eligible for Study: | up to 2 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Duke Univeristy Medical Center | |
Durham, North Carolina, United States, 27715 |
Principal Investigator: | Lauren Piper, MD | Duke University |
Responsible Party: | Duke Univeristy Medical Center ( Danny K. Benjamin MD, PhD, MPH ) |
Study ID Numbers: | 11454, NIH-5U10-HD-045962-04 |
Study First Received: | November 23, 2008 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00797420 |
Health Authority: | United States: Food and Drug Administration |
fluconazole pharmacokinetic candidiasis sepsis pediatric |
infants antifungal candidemia fungemia loading dose |
Fluconazole Mycoses Sepsis Candidiasis |
Clotrimazole Miconazole Tioconazole Fungemia |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Pharmacologic Actions |