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

Condition(s) targeted: Aspergillosis; Candidiasis

Intervention: caspofungin acetate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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).

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The proportion of patients with one or more drug-related clinical or laboratory adverse experience(s)

Secondary outcome:

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

Minimum age: 3 Months. Maximum age: 17 Years. Gender(s): Both.

Criteria:

- Children, 3 months through 17 years of age,

- with esophageal candidiasis or

- invasive candidiasis or

- children requiring salvage treatment of invasive aspergillosis.

Related 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.

Starting date: April 2004
Last updated: December 18, 2014