A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074 AM1)
The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in Japanese children and adolescents with documented Candida or Aspergillus infections.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Noncomparative, Open-label Study to Estimate the Safety, Efficacy, and Pharmacokinetics of MK-0991 (Caspofungin) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections|
- Overall response assessment for each infection category (esophageal candidiasis, invasive candidiasis, and aspergillosis) [ Time Frame: End of study therapy (7 to 84 days) ] [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Caspofungin (MK-0991) therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). A dose escalation of caspofungin to 70 mg/m^2/day, at the discretion of the investigator or sub-investigator, is allowed in patients who have not responded adequately after 4 days provided the study drug has been well tolerated (maximum should still not exceed 70 mg).
Maximum and minimum treatment periods for each infection category (esophageal candidiasis, invasive candidiasis, and aspergillosis) are as follows:
Aspergillosis: 14 to 84 days;
Invasive candidiasis: 14 to 56 days;
Esophageal candidiasis: 7 to 28 days