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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00761267 |
Anidulafungin (an antifungal drug) is relatively safe and the benefits outweigh the adverse effects when used in children diagnosed with invasive candidiasis, including candidemia.
Condition | Intervention | Phase |
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Candidemia Candidiasis |
Drug: anidulafungin Drug: fluconazole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Prospective, Open-Label Study To Assess The Pharmacokinetics, Safety & Efficacy Of Anidulafungin When Used To Treat Children With Invasive Candidiasis, Including Candidaemia |
Estimated Enrollment: | 60 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: anidulafungin
Day 1: loading dose of 3 mg/kg (not to exceed 200 mg) Day 2 onwards: maintain a dose of 1.5 mg/kg (not to exceed 100 mg). Minimum total treatment duration is 14 days. Minimum IV anidulafungin treatment duration is 10 days; followed by oral fluconazole 6-12 mg/kg/day (not to exceed 800mg/day). Maximum treatment duration with anidulafungin is 35 days. Maximum follow up duration is 6 weeks after the end of treatment. Minimum IV anidulafungin treatment duration is 10 days; followed by oral fluconazole 6-12 mg/kg/day (not to exceed 800mg/day). Switch of treatment to fluconazole may only occur after:
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Ages Eligible for Study: | 1 Month to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
United States, California | |
Pfizer Investigational Site | Not yet recruiting |
Oakland, California, United States, 94609 | |
Pfizer Investigational Site | Recruiting |
Orange, California, United States, 92868 | |
United States, Florida | |
Pfizer Investigational Site | Not yet recruiting |
Miami, Florida, United States, 33155 | |
United States, Massachusetts | |
Pfizer Investigational Site | Recruiting |
Boston, Massachusetts, United States, 02111 | |
United States, Mississippi | |
Pfizer Investigational Site | Recruiting |
Jackson, Mississippi, United States, 39216 | |
United States, Tennessee | |
Pfizer Investigational Site | Recruiting |
Knoxville, Tennessee, United States, 37916 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A8851008 |
Study First Received: | September 25, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00761267 |
Health Authority: | United States: Food and Drug Administration |
Anidulafungin, pediatrics, candidemia, invasive candidiasis, safety |
Fluconazole Mycoses Echinocandins Candidiasis Clotrimazole |
Miconazole Tioconazole Benzocaine Anidulafungin |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Antibiotics, Antifungal Pharmacologic Actions |