Documented Candida or Aspergillus Infections in Pediatric Patients (0991-043)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: May 11, 2004
Last updated: December 18, 2014
Last verified: December 2014
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
Drug: caspofungin acetate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The proportion of patients with one or more drug-related clinical or laboratory adverse experience(s)

Secondary Outcome Measures:
  • The proportion of patients who discontinued due to a drug-related AE or who have a serious drug-related AE
  • The proportion of patients with a favorable efficacy response to caspofungin therapy in each infection type

Enrollment: 50
Study Start Date: April 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: caspofungin acetate
    Duration of Treatment - 7-90 days
    Other Name: MK0991

Ages Eligible for Study:   3 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • Children, 3 months through 17 years of age,
  • with esophageal candidiasis or
  • invasive candidiasis or
  • children requiring salvage treatment of invasive aspergillosis.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00082524

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00082524     History of Changes
Other Study ID Numbers: 0991-043  Formerly-0404CCAI  MK0991-043  2004_100 
Study First Received: May 11, 2004
Last Updated: December 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Infectious
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses processed this record on April 27, 2016