Negative Beta Glucan in ICU Patients
Study Details
Study Description
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:
-
To assess the frequency of positive biomarkers in ICU patients at high risk to develop invasive candidiasis/candidemia;
-
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Anidulafungin Patients at risk will receive therapy with anidulafungin |
Drug: Anidulafungin
Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
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 <35 oC)
-
Hypotension
-
Unexplained acidosis
-
Unexplained elevation in C-reactive protein
Exclusion Criteria:
-
Antifungal for >3 days
-
Allergy to an echinocandin
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Federal University of Rio de Janeiro | Rio de Janeiro | RJ | Brazil | 21941913 |
Sponsors and Collaborators
- Universidade Federal do Rio de Janeiro
Investigators
- Study Chair: Marcio Nucci, MD, Universidade Federal do Rio de Janeiro
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Early Therapy
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Anidulafungin |
---|---|
Arm/Group Description | 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 |
Period Title: Overall Study | |
STARTED | 85 |
COMPLETED | 85 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | Anidulafungin |
---|---|
Arm/Group Description | 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 |
Overall Participants | 85 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
45
52.9%
|
>=65 years |
40
47.1%
|
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
63
|
Sex: Female, Male (Count of Participants) | |
Female |
44
51.8%
|
Male |
41
48.2%
|
Region of Enrollment (participants) [Number] | |
Brazil |
85
100%
|
Outcome Measures
Title | Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Anidulafungin |
---|---|
Arm/Group Description | 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 |
Measure Participants | 21 |
Candidemia |
0
0%
|
No candidemia |
21
24.7%
|
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | One Arm | |
Arm/Group Description | 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 | |
All Cause Mortality |
||
One Arm | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
One Arm | ||
Affected / at Risk (%) | # Events | |
Total | 0/85 (0%) | |
Other (Not Including Serious) Adverse Events |
||
One Arm | ||
Affected / at Risk (%) | # Events | |
Total | 0/85 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Marcio Nucci |
---|---|
Organization | Federal University of Rio de Janeiro |
Phone | 5521-39382463 |
mnucci@hucff.ufrj.br |
- Early Therapy