Caspofungin for the Treatment of Non-blood Candida Infections - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00083343

Purpose

Candida is the most common fungal pathogen identified in hospitalized patients. This study will seek to enroll adult patients (18 years of age or older) with invasive Candida infections (involving deep tissues and organs). The study will not enroll patients whose only site of Candida infection was the bloodstream. Patients that fulfill all study entry criteria will receive a single daily dose of caspofungin. Caspofungin, an intravenous echinocandin antifungal agent, is already approved for the treatment of invasive candidiasis. The dosage strength and duration of caspofungin will be individualized for each patient based on disease, severity of disease and extent of infection.

Condition	Intervention	Phase
Candidiasis	Drug: MK0991, caspofungin acetate/Duration of Treatment: variable	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicenter, Open, Noncomparative Study to Estimate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in the Treatment of Adults With Invasive Candida Infections (Excluding Patients With Candidemia as the Sole Site of Infection)

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections

Drug Information available for: Caspofungin Caspofungin Acetate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Favorable overall response rate

Secondary Outcome Measures:

Favorable overall response rate on Day 10 of caspofungin therapy
Occurance of relapse during the 12 week follow-up period following the completion of all antifungal therapy

Estimated Enrollment:	50
Study Start Date:	August 2004
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients must have at least 1 positive culture for Candida species obtained from an otherwise sterile, non-blood body site within 96 hours of the study entry.
The patient must also have clinical evidence of Candida infection (e.g., oral temperature >100 degrees Fahrenheit, signs of inflammation from infected site, systolic blood pressure <90) within 96 hours of study entry.
The patient must be at least 18 years old, and if a woman of child bearing potential, must have a negative serum or urine pregnancy test sensitive to 25 IU HCG prior to enrollment.

Exclusion Criteria:

Patients whose only site of Candida infection was the bloodstream.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083343

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Petrovic J, Ngai A, Bradshaw S, Williams-Diaz A, Taylor A, Sable C, Vuocolo S, Kartsonis N. Efficacy and safety of caspofungin in solid organ transplant recipients. Transplant Proc. 2007 Dec;39(10):3117-20.

Responsible Party:	Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_102, Formerly-0404NBCI, MK0991-045
Study First Received:	May 20, 2004
Last Updated:	January 21, 2010
ClinicalTrials.gov Identifier:	NCT00083343 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Mycoses
Echinocandins
Candidiasis

Therapeutic Uses
Antifungal Agents
Caspofungin
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 18, 2010