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| Sponsored by: |
Astellas Pharma Inc |
| Information provided by: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00607763 |
Purpose
Infants and toddlers with fungal infections will receive 10 to 14 days of treatment with an antifungal drug. Safety and drug blood levels will be assessed
| Condition | Intervention | Phase |
|
Invasive Candidiasis Esophageal Candidiasis Oropharyngeal Candidiasis Candidemia |
Drug: Micafungin |
Phase I |
| MedlinePlus related topics: | Esophagus Disorders Fungal Infections Molds Yeast Infections |
| ChemIDplus related topics: | Clotrimazole Miconazole Miconazole nitrate Tioconazole Micafungin FK 463 |
| Study Type: | Interventional |
| Study Design: | Other, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | A Phase 1, Open-Label Study Of The Safety And Pharmacokinetics Of Repeated-Dose Micafungin (FK463) In Infants And Toddlers (≥4 Months TO < 24 Months Of Age) With Esophageal Candidiasis Or Other Invasive Candidiasis |
| Estimated Enrollment: | 8 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | September 2008 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Drug: Micafungin
IV
|
This is a prospective, multicenter, open-label, repeat-dose study. Subjects will receive treatment with intravenous micafungin for 10 to 14 days (per investigator clinical judgment) at a daily dose of 4.5 mg/kg (determined by the subject's weight at baseline). Serial blood samples for assessment of pharmacokinetics will be collected.
Eligibility
| Ages Eligible for Study: | 4 Months to 23 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Astellas Pharma US Medical Information | 800-888-7704 ext 5473 | clintrials.info@us.astellas.com |
| United States, California | |||||
| Recruiting | |||||
| Orange, California, United States, 92868 | |||||
| United States, Kentucky | |||||
| Recruiting | |||||
| Louisville, Kentucky, United States, 40202 | |||||
| United States, Missouri | |||||
| Recruiting | |||||
| Kansas City, Missouri, United States, 64108 | |||||
| United States, Texas | |||||
| Recruiting | |||||
| Dallas, Texas, United States, 75390 | |||||
| Recruiting | |||||
| Houston, Texas, United States, 77030 | |||||
| Astellas Pharma Inc |
| Study Director: | Central Contact | Astellas Pharma US, Inc. |
More Information
| Responsible Party: | Astellas Pharma US, Inc. ( Sr Manager Clinical Trial Registry ) |
| Study ID Numbers: | 9463-CL-2102 |
| First Received: | January 23, 2008 |
| Last Updated: | September 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00607763 |
| Health Authority: | United States: Food and Drug Administration |
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