Caspofungin to Prevent Candidiasis in Adults in Hospital Intensive Care Units
Status:
Completed
Trial end date:
2005-09-01
Target enrollment:
Participant gender:
Summary
This study will examine whether the anti-fungal drug caspofungin can prevent Candida
infections in adult patients in intensive care units (ICUs). Caspofungin is approved to treat
certain fungal infections, including fungal blood stream infections due to Candida. Because
ICU patients are at high risk for Candida, it would be beneficial to have a preventive drug,
thereby reducing complications due to infection.
Patients 18 years of age or older who are not pregnant may be enrolled in this study on day 3
or 4 of their ICU admission if they have an expected stay of at least 2 additional days in
the ICU.
Participants are randomly assigned to treatment with either caspofungin or placebo (an
inactive substance). Before treatment, patients have a medical history and physical
examination. Blood and urine tests are done for routine tests and to look for fungal
infection. Additional samples that may be collected to test for fungal infection include a
rectal swab or stool sample; a wound culture if the patient has a wound, or a sputum culture
in patients who have a tube in their throat to help with breathing or are producing sputum.
Patients take caspofungin or placebo once a day for no more than 28 days. In addition, they
undergo the following procedures:
- Review of treatment side effects and medicines taken, daily during treatment, 1 week
after treatment, and 2 weeks after treatment
- Physical examination once a week, on the last day of treatment, and 1 week after
treatment
- Urine test once a week, on the last day of treatment, and 1 week after treatment to look
for possible fungal infection
- Blood tests twice a week, on the last day of treatment, 1 week after treatment, and 2
weeks after treatment for laboratory safety tests and to look for fungal infection
- Collection of additional samples (rectal swab or stool sample, wound culture, or sputum
sample) once a week, on the last day of treatment, and 1 week after treatment to look
for possible fungal infection