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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00082524
First received: May 11, 2004
Last updated: December 18, 2014
Last verified: December 2014

May 11, 2004
December 18, 2014
April 2004
July 2007   (final data collection date for primary outcome measure)
The proportion of patients with one or more drug-related clinical or laboratory adverse experience(s)
Not Provided
Complete list of historical versions of study NCT00082524 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Documented Candida or Aspergillus Infections in Pediatric Patients (0991-043)
A Multicenter, Open-Label, Noncomparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in Children With Documented Candida or Aspergillus Infections

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).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aspergillosis
  • Candidiasis
Drug: caspofungin acetate
Duration of Treatment - 7-90 days
Other Name: MK0991
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2007
July 2007   (final data collection date for primary outcome measure)
  • Children, 3 months through 17 years of age,
  • with esophageal candidiasis or
  • invasive candidiasis or
  • children requiring salvage treatment of invasive aspergillosis.
Both
3 Months to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States,   Germany,   Italy,   New Zealand,   Taiwan,   Belgium,   Israel
 
NCT00082524
0991-043, Formerly-0404CCAI, MK0991-043, 2004_100
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP