Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099775
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-12-18
Brief Title:
Caspofungin to Prevent Candidiasis in Adults in Hospital Intensive Care Units
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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 events and to evaluate all-cause mortality The planned sample size will be 1200 subjects 13 in the control arm and 23 in the active treatment arm based on a power of at least 08 needed to detect a 50 reduction in incidence from base rate of 11 to 55 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 mgday 70 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-C-0057 | None | None | None |