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Negative Beta Glucan in ICU Patients

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ClinicalTrials.gov Identifier: NCT01734525
Recruitment Status : Completed
First Posted : November 27, 2012
Results First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Marcio Nucci, Universidade Federal do Rio de Janeiro

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.

Condition or disease Intervention/treatment Phase
Candidemia Drug: Anidulafungin 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study for the Use of Biomarkers and Early Treatment of Invasive Candidiasis in ICU Patients
Study Start Date : November 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734525


Locations
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Brazil
Federal University of Rio de Janeiro
Rio de Janeiro, RJ, Brazil, 21941913
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
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Study Chair: Marcio Nucci, MD Universidade Federal do Rio de Janeiro
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marcio Nucci, MD, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01734525    
Other Study ID Numbers: Early Therapy
First Posted: November 27, 2012    Key Record Dates
Results First Posted: July 8, 2019
Last Update Posted: July 8, 2019
Last Verified: April 2019
Keywords provided by Marcio Nucci, Universidade Federal do Rio de Janeiro:
candidemia
intensive care unit
1,3 beta-D-glucan
Additional relevant MeSH terms:
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Candidemia
Fungemia
Sepsis
Infection
Candidiasis, Invasive
Candidiasis
Mycoses
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anidulafungin
Antifungal Agents
Anti-Infective Agents