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

• Sponsor: Merck Sharp & Dohme Corp. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00083343
• Collaborator: (none)
• Enrollment: 48
• Duration (Months): 21.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Candidiasis	Drug: MK0991, caspofungin acetate/Duration of Treatment: variable	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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)
• Study Start Date: May 1, 2004
• Actual Primary Completion Date: Feb 1, 2006
• Actual Study Completion Date: Feb 1, 2006

Outcome Measures

Primary Outcome Measures

1. Favorable overall response rate []

Secondary Outcome Measures

1. Favorable overall response rate on Day 10 of caspofungin therapy []

2. Occurance of relapse during the 12 week follow-up period following the completion of all antifungal therapy []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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

• 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.
• ClinicalTrials.gov Identifier: NCT00083343
• Other Study ID Numbers: 0991-045; Formerly-0404NBCI; MK0991-045; 2004_102
• First Posted: May 24, 2004
• Last Update Posted: Feb 23, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Candidiasis; Caspofungin

Study Results

No Results Posted as of Feb 23, 2017