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

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.
ClinicalTrials.gov Identifier: NCT00082524
Recruitment Status : Completed
First Posted : May 13, 2004
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Aspergillosis Candidiasis Drug: caspofungin acetate Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
Study Start Date : April 2004
Primary Completion Date : July 2007
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: caspofungin acetate
    Duration of Treatment - 7-90 days
    Other Name: MK0991

Outcome Measures

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

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

Eligibility Criteria

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 Posted: May 13, 2004    Key Record Dates
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