Phase 4
N=222
Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU)
Invasive Candidiasis
Bottom Line
View on ClinicalTrials.gov: NCT00520234 ↗Enrolled (actual)
222
Serious AEs
27.9%
Results posted
May 2011
Primary outcome: Primary: Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria. — 9.8; 16.6 percent of participants — p=0.14
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Caspofungin (Drug); Normal Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mycoses Study Group
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria. |
9.8; 16.6 | 0.14 |
| SECONDARY Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria. |
— | — |
| SECONDARY All Cause Mortality |
— | — |
| SECONDARY Initiation of Other Antifungals |
— | — |
| SECONDARY Time to Development of Proven or Probable Invasive Candidiasis |
— | — |
| SECONDARY Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis. |
— | — |
| SECONDARY Time to Beta Glucan Negativity in Pre-emptive Phase. |
— | — |
| SECONDARY Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase. |
— | — |
| SECONDARY Hospital Metrics (to be Evaluated Separately for Prophylaxis and Pre-emptive Therapy Phases); Length of Stay in the Hospital, Length of Stay in the ICU, and the Costs Data for the ICU Stay and the Hospitalization, if Available. |
— | — |
| SECONDARY Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event |
2; 2 | — |
| SECONDARY Subjects With 1 or More Serious Drug-related Adverse Event(s) |
1; 0 | — |
Summary
Adults admitted to intensive care units are at risk for a variety of complications. Infections due to the fungus called candida are of particular concern. The study will test the possibility that caspofungin, a new therapy for fungal infections, can successfully reduce the rate of candida infections in subjects at risk. It will also test if caspofungin is useful in treating subjects for this disease when diagnosed using a new blood test that is performed twice weekly, permitting earlier diagnosis than current practice standards.
Eligibility Criteria
Inclusion Criteria
- Non-pregnant >18 yrs of age
- Subjects admitted to ICU during the preceding 3 days and expected to stay in the ICU for at least another 48 hours.Subjects can be enrolled on days 3-5 of ICU admission.
- Subjects meeting the clinical prediction rule
Exclusion Criteria
- Subjects with an allergy/intolerance to caspofungin or echinocandin analog
- absolute neutrophil count <500/mm3 at study entry or likely to develop such a count during therapy
- acquired immunodeficiency syndrome, aplastic anemia or chronic granulomatous disease
- moderate or severe hepatic insufficiency
- subjects who are pregnant or lactating
- unlikely to survive < 24 hours
- subjects who have received systemic antifungal therapy within 10 days prior to study entry
- Documented active proven or probable invasive fungal infection upon enrollment
- previously enrolled in this study
- Currently on another investigational agent or have received an investigational agent within 10 days prior to study entry.
Data sourced from ClinicalTrials.gov (NCT00520234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.