Candidemia
Conditions
Keywords
candidemia, intensive care unit, 1,3 beta-D-glucan
Brief 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.
Detailed description
Entry criteria are: In the ICU for \>2 days AND systemic antibiotics \>2 days OR central venous catheter for \>days AND at least two of the following: total parenteral nutrition, dialysis, surgery, pancreatitis, receipt of corticosteroids, receipt of other immunosuppressive agents. In addition, patients must have a clinical sign of infection (either one of the following): fever, hypothermia, hypotension, unexplained acidosis, or unexplained elevation in C-reactive protein. Eligible patients will be enrolled after signing an informed consent and will have blood obtained for culture and determination of 1,3 beta-D-glucan serum levels for 3 days, and will start anidulafungin IV. If all tests are negative, anidulafungin will be discontinued on day 4. If 1,3 beta-D-glucan is positive (\>80 pg/ml) and / or blood cultures are positive for Candida species, anidulafungin will be continued for \>14 days.
Interventions
DRUGAnidulafungin
Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards
Sponsors
Universidade Federal do Rio de Janeiro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \<35 oC) * Hypotension * Unexplained acidosis * Unexplained elevation in C-reactive protein
Exclusion criteria
* Antifungal for \>3 days * Allergy to an echinocandin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin | 30 days | The main interest is to evaluate the ocurrence of candidemia in patients with negative 1,3 beta-D-glucan who discontinue anidulafungin |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anidulafungin Patients at risk will receive therapy with anidulafungin
Anidulafungin: Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards | 85 |
| Total | 85 |
Baseline characteristics
| Characteristic | Anidulafungin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 40 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Age, Continuous | 63 years |
| Region of Enrollment Brazil | 85 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 85 |
| serious Total, serious adverse events | 0 / 85 |
Outcome results
Primary
Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin
The main interest is to evaluate the ocurrence of candidemia in patients with negative 1,3 beta-D-glucan who discontinue anidulafungin
Time frame: 30 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anidulafungin | Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin | Candidemia | 0 Participants |
| Anidulafungin | Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin | No candidemia | 21 Participants |