A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis, Esophageal; Candidiasis, Invasive; Aspergillosis
Intervention: Caspofungin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
Summary
The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in
Japanese children and adolescents with documented Candida or Aspergillus infections.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants With an Overall Favorable Response to TherapyPercentage of Participants With One or More Drug-Related Adverse Experiences
Eligibility
Minimum age: 3 Months.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Japanese patients in whom a causative fungus is detected before treatment with the
study drug or patients with strongly suspected deep-seated fungal infection due to
Candida species (spp.) or Aspergillus spp.
Exclusion Criteria:
- Patients with mycoses other than ones due to Candida spp. or Aspergillus spp.
- Patients who will receive other systemic antifungal agents for the first time in
screening period
Locations and Contacts
Additional Information
Starting date: July 2010
Last updated: July 20, 2015
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