Documented Candida or Aspergillus Infections in Pediatric Patients (0991-043)
Primary Purpose
Aspergillosis, Candidiasis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
caspofungin acetate
Sponsored by
About this trial
This is an interventional treatment trial for Aspergillosis
Eligibility Criteria
Children, 3 months through 17 years of age, with esophageal candidiasis or invasive candidiasis or children requiring salvage treatment of invasive aspergillosis.
Sites / Locations
Outcomes
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
Full Information
NCT ID
NCT00082524
First Posted
May 11, 2004
Last Updated
February 20, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00082524
Brief Title
Documented Candida or Aspergillus Infections in Pediatric Patients (0991-043)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspergillosis, Candidiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
caspofungin acetate
Other Intervention Name(s)
MK0991
Intervention Description
Duration of Treatment - 7-90 days
Primary Outcome Measure Information:
Title
The proportion of patients with one or more drug-related clinical or laboratory adverse experience(s)
Secondary Outcome Measure Information:
Title
The proportion of patients who discontinued due to a drug-related AE or who have a serious drug-related AE
Title
The proportion of patients with a favorable efficacy response to caspofungin therapy in each infection type
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Children, 3 months through 17 years of age,
with esophageal candidiasis or
invasive candidiasis or
children requiring salvage treatment of invasive aspergillosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19255017
Citation
Zaoutis TE, Jafri HS, Huang LM, Locatelli F, Barzilai A, Ebell W, Steinbach WJ, Bradley J, Lieberman JM, Hsiao CC, Seibel N, Laws HJ, Gamba M, Petrecz M, Taylor AF, Strohmaier KM, Chow JW, Kartsonis NA, Ngai AL. A prospective, multicenter study of caspofungin for the treatment of documented Candida or Aspergillus infections in pediatric patients. Pediatrics. 2009 Mar;123(3):877-84. doi: 10.1542/peds.2008-1158.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSRSynopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Documented Candida or Aspergillus Infections in Pediatric Patients (0991-043)
We'll reach out to this number within 24 hrs