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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.
May 11, 2004
May 13, 2004
February 23, 2017
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
Intervention Model: Single Group Assignment
Masking: None (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.
Sexes Eligible for Study: All
3 Months to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Belgium,   Germany,   Israel,   Italy,   New Zealand,   Taiwan,   United States
 
NCT00082524
0991-043
Formerly-0404CCAI
MK0991-043
2004_100
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2017

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