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NCT00082524 Clinical Trial

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

Candidiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00082524
Other study ID # 0991-043
Secondary ID Formerly-0404CCA
Status Completed
Phase Phase 2
First received May 11, 2004
Last updated February 20, 2017
Start date April 2004
Est. completion date July 2007

Study information
Verified date February 2017
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender All
Age group 3 Months to 17 Years
Eligibility - Children, 3 months through 17 years of age,

- with esophageal candidiasis or

- invasive candidiasis or

- children requiring salvage treatment of invasive aspergillosis.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• caspofungin acetate
Duration of Treatment - 7-90 days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The proportion of patients with one or more drug-related clinical or laboratory adverse experience(s)
Secondary The proportion of patients who discontinued due to a drug-related AE or who have a serious drug-related AE
Secondary The proportion of patients with a favorable efficacy response to caspofungin therapy in each infection type
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