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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 Therapy

Percentage 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

Page last updated: August 20, 2015

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