Skip to main content
OpenTrials
Completed

NCT Number: NCT00083343

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Candidiasis Bacterial Infections and Mycoses Infections Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MK0991, caspofungin acetate/Duration of Treatment: variable

Drug

Primary outcomes

  1. Favorable overall response rate

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
May 24, 2004
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.