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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):
Merck Sharp & Dohme LLC

Tracking Information
First Submitted Date  ICMJE May 11, 2004
First Posted Date  ICMJE May 13, 2004
Last Update Posted Date February 23, 2017
Study Start Date  ICMJE April 2004
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2005)		 The proportion of patients with one or more drug-related clinical or laboratory adverse experience(s)
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Documented Candida or Aspergillus Infections in Pediatric Patients (0991-043)
Official Title  ICMJE A Multicenter, Open-Label, Noncomparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in Children With Documented Candida or Aspergillus Infections
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aspergillosis
  • Candidiasis
Intervention  ICMJE Drug: caspofungin acetate
Duration of Treatment - 7-90 days
Other Name: MK0991
Study Arms  ICMJE Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2005)		 50
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • Children, 3 months through 17 years of age,
  • with esophageal candidiasis or
  • invasive candidiasis or
  • children requiring salvage treatment of invasive aspergillosis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Belgium,   Germany,   Israel,   Italy,   New Zealand,   Taiwan,   United States
 
Administrative Information
NCT Number  ICMJE NCT00082524
Other Study ID Numbers  ICMJE 0991-043
Formerly-0404CCAI
MK0991-043
2004_100
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Merck Sharp & Dohme LLC
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Merck Sharp & Dohme LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme LLC
PRS Account Merck Sharp & Dohme LLC
Verification Date February 2017

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