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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00082524
First Posted: May 13, 2004
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Single Group Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082524


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

Publications:
Study Data/Documents: CSRSynopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00082524     History of Changes
Other Study ID Numbers: 0991-043
Formerly-0404CCAI
MK0991-043
2004_100
First Submitted: May 11, 2004
First Posted: May 13, 2004
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Candidiasis
Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Caspofungin
Echinocandins
Antifungal Agents
Anti-Infective Agents