Caspofungin to Prevent Candidiasis in Adults in Hospital Intensive Care Units
Tracking Information | |
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First Received Date ICMJE | December 18, 2004 |
Last Updated Date | March 3, 2008 |
Start Date ICMJE | December 2004 |
Primary Completion Date | |
Current Primary Outcome Measures ICMJE | |
Original Primary Outcome Measures ICMJE | |
Change History | Complete list of historical versions of study NCT00099775 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Caspofungin to Prevent Candidiasis in Adults in Hospital Intensive Care Units |
Official Title ICMJE | A Randomized Double-Masked Trial of Caspofungin Versus Placebo as Prophylaxis of Invasive Candidiasis in High-Risk Adults in the Critical Care Setting |
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:
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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 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. |
Study Type ICMJE | Interventional |
Study Phase | Phase 3 |
Study Design ICMJE | Endpoint Classification: Efficacy Study Primary Purpose: Treatment |
Condition ICMJE | Candidiasis |
Intervention ICMJE | Drug: Caspofungin |
Study Arm (s) | |
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 1200 |
Completion Date | September 2005 |
Primary Completion Date | |
Eligibility Criteria ICMJE | INCLUSION CRITERIA Subjects who meet all of the following criteria are eligible for enrollment into the study: Participant, or their legal representative, has signed the informed consent. Sites will follow their institutional review board (IRB) specific guidelines for obtaining informed consent. Admission to an ICU within the previous 3 days. The subject may be enrolled into this study on Days 3, 4 or 5 of the ICU admission, and MUST HAVE an expected stay of at least 2 additional days in the ICU. NOTE: The day the subject is admitted to the ICU is Day 1 of ICU Admission. All days are counted in calendar days. Non-pregnant subjects greater than or equal to 18 years of age. Subjects of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to study entry. Subject must have at least 1 of the following: Received at least one dose of any systemic antibiotic on any one of the ICU days before study entry and continue to receive antibiotics at the time of enrollment. Presence of a central venous catheter at time of enrollment and for 1 additional day during current ICU stay. And at least 2 of the following:
EXCLUSION CRITERIA Subjects who meet any of the following criteria are ineligible for enrollment in the study:
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Gender | Both |
Ages | |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States |
Administrative Information | |
NCT Number ICMJE | NCT00099775 |
Other Study ID Numbers ICMJE | 050057, 05-C-0057 |
Has Data Monitoring Committee | |
Responsible Party | |
Study Sponsor ICMJE | National Cancer Institute (NCI) |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | National Institutes of Health Clinical Center (CC) |
Verification Date | September 2005 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |