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

• Sponsor: Merck Sharp & Dohme Corp. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00082524
• Collaborator: (none)
• Enrollment: 50
• Duration (Months): 39

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Aspergillosis; Candidiasis	Drug: caspofungin acetate	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Apr 1, 2004
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Outcome Measures

Primary Outcome Measures

1. The proportion of patients with one or more drug-related clinical or laboratory adverse experience(s) []

Secondary Outcome Measures

1. The proportion of patients who discontinued due to a drug-related AE or who have a serious drug-related AE []

2. The proportion of patients with a favorable efficacy response to caspofungin therapy in each infection type []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• Children, 3 months through 17 years of age,

• with esophageal candidiasis or

• invasive candidiasis or

• children requiring salvage treatment of invasive aspergillosis.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme Corp.

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme Corp.

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00082524
• Other Study ID Numbers: 0991-043; Formerly-0404CCAI; MK0991-043; 2004_100
• First Posted: May 13, 2004
• Last Update Posted: Feb 23, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Candidiasis; Aspergillosis; Caspofungin

Study Results

No Results Posted as of Feb 23, 2017