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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00330395 |
The purpose of this study is to test the amount of caspofungin found in the blood of neonate and infants <3 months of age following treatment with caspofungin at 25 mg/m2. Another purpose is to test the safety of caspofungin in treating neonates and infants with Candida infections (a certain type of fungal infection).
Condition | Intervention | Phase |
---|---|---|
Candidiasis |
Drug: caspofungin acetate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Multicenter, Sequential-Panel, Open-Label, Noncomparative Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Caspofungin Acetate in Neonates and Infants Less Than 3 Months of Age. |
Enrollment: | 16 |
Study Start Date: | May 2006 |
Study Completion Date: | December 2006 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 3 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2006_025, MK0991-058 |
Study First Received: | May 24, 2006 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00330395 |
Health Authority: | United States: Food and Drug Administration |
Mycoses Echinocandins Candidiasis Clotrimazole |
Miconazole Caspofungin Tioconazole |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Pharmacologic Actions |