A Pilot Study for the Use of Biomarkers and Early Treatment of Invasive Candidiasis in Intensive Care Unit (ICU) Patients

This study is currently recruiting participants.
Verified November 2012 by Universidade Federal do Rio de Janeiro
Sponsor:
Information provided by (Responsible Party):
Marcio Nucci, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01734525
First received: November 20, 2012
Last updated: November 26, 2012
Last verified: November 2012

November 20, 2012
November 26, 2012
November 2012
August 2013   (final data collection date for primary outcome measure)
Exploratory analysis of the kinetics of 1,3 beta-D-glucan in hig-risk patients [ Time Frame: 30 days ] [ Designated as safety issue: No ]
The main interst is to evaluate the kinetics of 1,3 beta-D-glucan in hig-risk patients receiving anidulafungin.
Same as current
Complete list of historical versions of study NCT01734525 on ClinicalTrials.gov Archive Site
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A Pilot Study for the Use of Biomarkers and Early Treatment of Invasive Candidiasis in Intensive Care Unit (ICU) Patients
Pilot Study of Biomarkers in Invasive Candidiasis in Intensive Care Unit (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. Likewise, analyzing the kinetics of these biomarkers in patients with candidemia/invasive candidiasis would help to define their usefulness in monitoring treatment.

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 evaluate the kinetics of positive biomarkers after initiation of antifungal therapy in patients with candidemia;
  3. 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.

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, unexplanied 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. Blood will oe collected for determination of 1,3 beta-D-glucan on days 7, 10, 14, 17, 21, 24 and 28.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Candidemia
Drug: Anidulafungin
Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards
Other Name: Anidulafungin
Experimental: One arm
Patients at risk will receive therapy with anidulafungin
Intervention: Drug: Anidulafungin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
September 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
Brazil
 
NCT01734525
Early Therapy
No
Marcio Nucci, Federal University of Rio de Janeiro
Universidade Federal do Rio de Janeiro
Not Provided
Study Chair: Marcio Nucci, MD Universidade Federal do Rio de Janeiro
Universidade Federal do Rio de Janeiro
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP