Caspofungin to Prevent Candidiasis in Adults in Hospital Intensive Care Units
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
|Study Design:||Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
|Official Title:||A Randomized Double-Masked Trial of Caspofungin Versus Placebo as Prophylaxis of Invasive Candidiasis in High-Risk Adults in the Critical Care Setting|
|Study Start Date:||December 2004|
|Estimated Study Completion Date:||September 2005|
This study is designed as a prospective, multi-center randomized double-masked placebo-controlled trial of caspofungin versus placebo for prevention of invasive candidiasis in high-risk adults in the critical care setting. The objective of this study is to evaluate the efficacy of caspofungin as prophylaxis for invasive candidiasis in high-risk ICU subjects by comparing the risk of invasive candidiasis in subjects receiving caspofungin with the risk in those receiving placebo. The secondary objectives are to evaluate the rate of invasive candidiasis in subjects meeting the clinical prediction rule; to prospectively assess the effect of colonization as a risk factor for the development of invasive candidiasis; to evaluate the safety of caspofungin as prophylaxis for invasive candidiasis by summarizing the proportion of subjects who discontinue study therapy because of a drug-related adverse event and the proportion of subjects with one or more drug-related adverse event(s); and to evaluate all-cause mortality. The planned sample size will be 1200 subjects, 1/3 in the control arm and 2/3 in the active treatment arm based on a power of at least 0.8 needed to detect a 50% reduction in incidence from base rate of 11% to 5.5%. High-risk icu subjects greater than or equal to 18 years of age meeting all eligibility criteria with at least 5 days of anticipated ICU stay will be randomized to receive either caspofungin 50 mg/day (70 mg/day for subjects on rifampin) or placebo (normal saline) daily. Caspofungin or placebo will be given intravenously as a single daily dose infused over approximately one hour. Subjects will receive study drug or placebo for the duration on their icu stay, up to a maximum of 28 days.
|United States, Maryland|
|National Cancer Institute (NCI)|
|Bethesda, Maryland, United States, 20892|