Documented Candida or Aspergillus Infections in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00082524
First received: May 11, 2004
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

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 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: May 2004
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
  Eligibility

Ages Eligible for Study:   3 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082524

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

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00082524     History of Changes
Other Study ID Numbers: 2004_100, Formerly-0404CCAI, MK0991-043
Study First Received: May 11, 2004
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Aspergillosis
Candidiasis
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Caspofungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014