Documented Candida or Aspergillus Infections in Pediatric Patients - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00082524

Purpose

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	Intervention	Phase
Aspergillosis Candidiasis	Drug: caspofungin acetate	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Aspergillosis Yeast Infections

Drug Information available for: Caspofungin Caspofungin Acetate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	50
Study Start Date:	May 2004
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Duration of Treatment - 7-90 days

Other Name: MK0991

Eligibility

Ages Eligible for Study:	3 Months to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082524

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

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.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00082524 History of Changes
Other Study ID Numbers:	2004_100, Formerly-0404CCAI, MK0991-043
Study First Received:	May 11, 2004
Last Updated:	January 21, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Aspergillosis
Candidiasis
Mycoses
Caspofungin
Echinocandins

Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2012