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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00082524 |
This study is an open label, noncomparative study using an investigational agent for the treatment of documented Candida or Aspergillus infections in pediatric patients (ages 3 months-17 years).
Condition | Intervention | Phase |
---|---|---|
Aspergillosis Candidiasis |
Drug: caspofungin acetate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Multicenter, Open-Label, Noncomparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in Children With Documented Candida or Aspergillus Infections |
Enrollment: | 50 |
Study Start Date: | May 2004 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 3 Months to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2004_100, Formerly-0404CCAI, MK0991-043 |
Study First Received: | May 11, 2004 |
Last Updated: | May 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00082524 |
Health Authority: | United States: Food and Drug Administration |
Mycoses Echinocandins Candidiasis Clotrimazole Miconazole |
Caspofungin Tioconazole Aspergillosis Torulopsis |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Pharmacologic Actions |