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

Candidiasis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00083343
• Other study ID #: 0991-045
• Secondary ID: Formerly-0404NBC
• Status: Completed
• Phase: Phase 2
• First received: May 20, 2004
• Last updated: February 20, 2017
• Start date: May 2004
• Est. completion date: February 2006

Study information

• Verified date: February 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Conditions & MeSH terms

• Candidiasis

Intervention

Drug:
• MK0991, caspofungin acetate/Duration of Treatment: variable

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Favorable overall response rate
Secondary	Favorable overall response rate on Day 10 of caspofungin therapy
Secondary	Occurance of relapse during the 12 week follow-up period following the completion of all antifungal therapy