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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01734525
Other study ID # Early Therapy
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 2012
Est. completion date December 2013

Study information

Verified date April 2019
Source Universidade Federal do Rio de Janeiro
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Brazil Federal University of Rio de Janeiro Rio de Janeiro RJ

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
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 30 days
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