Negative Beta Glucan in ICU Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Candidemia Bacterial Infections and Mycoses Candidiasis Candidiasis, Invasive Fungemia Infections Inflammation Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Federal University of Rio de Janeiro

Rio de Janeiro, 21941913, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anidulafungin

Drug

Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards

Primary outcomes

Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin

Time frame: 30 days

The main interest is to evaluate the ocurrence of candidemia in patients with negative 1,3 beta-D-glucan who discontinue anidulafungin

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Registry information

Official study title

A Pilot Study for the Use of Biomarkers and Early Treatment of Invasive Candidiasis in ICU Patients

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Nov 27, 2012
Registry last updated: Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed