Status:
COMPLETED
Caspofungin to Prevent Candidiasis in Adults in Hospital Intensive Care Units
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Candidiasis
Eligibility:
All Genders
Phase:
PHASE3
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 infect...
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 ...
Eligibility Criteria
Inclusion
- 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:
- Use of total parenteral nutrition on any of Days 1-4 of the ICU admission.
- Any type dialysis on any of Days 1-4 of the ICU admission.
- Any in-patient surgery, done under general anesthesia or epidural block, within the 7 days prior to or on ICU admission. (Excludes placement of vascular catheters.)
- Pancreatitis (documented by CT scan or lipase greater than 1,000 u/L) within the 7 days prior to or on ICU admission.
- More than 1 dose of systemic steroids (prednisone equivalent dose greater than or equal to 20 mg per day) between 7 days prior to and through Day 3 of ICU admission.
- Use of more than 1 dose of other systemic immunosuppressive agents (such as azathioprine, tacrolimus, sirolimus, mycophenolate, monoclonal antibodies, and TNF immunomodulators) within the 7 days prior to or on ICU admission.
- EXCLUSION CRITERIA
- Subjects who meet any of the following criteria are ineligible for enrollment in the study:
- Allergy or intolerance to caspofungin or any other echinocandin analog.
- Absolute neutrophil count less than 500/mm(3) at study entry or likely to develop such an absolute neutrophil count during the study therapy period.
- A diagnosis of HIV, aplastic anemia, or chronic granulomatous disease.
- Moderate or severe hepatic insufficiency as indicated by a Child-Pugh Score of 7 or higher or cirrhosis due to any cause (Child-Pugh scores are to be calculated only if hepatic insufficiency is suspected.
- Women who are pregnant or breastfeeding.
- Subjects unlikely to survive more than 2 days.
- Subjects who have received a systemic antifungal agent for treatment or prophylaxis within 7 days prior to study entry.
- Subjects with documented active, proven or probable IFI within 7 days prior to study entry.
- Subjects who have previously participated in this study.
- Subjects who have received another investigational agent within 7 days prior to study entry or who are currently receiving another investigational agent.
- Subjects in the ICU greater than 5 days prior to enrollment into this study.
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00099775
Start Date
December 1 2004
End Date
September 1 2005
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892