Caspofungin for the Treatment of Non-blood Candida Infections (0991-045)

Condition(s) targeted: Candidiasis

Intervention: MK0991, caspofungin acetate/Duration of Treatment: variable (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.

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.

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)

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

Primary outcome: Favorable overall response rate

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Related 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.

Starting date: May 2004
Last updated: December 10, 2014