Phase 4
N=85
Negative Beta Glucan in ICU Patients
Candidemia
Bottom Line
View on ClinicalTrials.gov: NCT01734525 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin — 0; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Anidulafungin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universidade Federal do Rio de Janeiro
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin |
0; 21 | — |
Summary
This is a prospective study aimed at testing a strategy of early initiation of an antifungal agent to patients admitted to intensive care units (ICUs) at risk for invasive candidiasis. Score system have been developed to identify groups at very high risk for the development of candidemia/invasive candidiasis in the ICU. These scoring system have used clinical information with or without data on Candida colonization, and have shown reasonable correlation with candidemia/invasive candidiasis. More recently, a biomarker - detection of 1,3-beta-D-glucan in the serum - has been tested in the early diagnosis of candidiasis. The incorporation of biomarkers such as beta-D-glucan could help clinicians to select a group at higher risk for candidemia, and despite the fact that these tests may give false-positive results, their negative predictive value could be of great help.
Therefore, the objectives of this study are:
1. To assess the frequency of positive biomarkers in ICU patients at high risk to develop invasive candidiasis/candidemia;
2. To test the strategy of early discontinuation of antifungal therapy based on repeatedly negative blood cultures and 1,3 beta-D-glucan in the serum.
Eligibility Criteria
Inclusion Criteria
- In the ICU for >2 days AND
- Systemic antibiotics on days 1-3 of ICU OR
- Central venous catheter on days 1-3 of ICU
- AND at least 2 of:
- Total parenteral nutrition on days 1-3 of ICU
- Any dialysis on days 1-3 of ICU
- Major surgery in the 7 days before admission in the ICU
- Pancreatitis in the 7 days before admission in the ICU
- Use of corticosteroids for at least 3 days in the 7 days before admission
- Use of other immunosuppressive agents in the 7 days before admission in the ICU
- In addition, the patient must have at least one of the following:
- Fever (axillary temperature >37.5 oC)
- Hypothermia (axillary temperature 3 days
- Allergy to an echinocandin
Data sourced from ClinicalTrials.gov (NCT01734525). 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.