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. (see Contacts and Locations)
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
  Purpose

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.

Condition Intervention Phase
Candidemia
Drug: Anidulafungin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Biomarkers in Invasive Candidiasis in Intensive Care Unit (ICU) Patients

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: One arm
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
Other Name: Anidulafungin

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, 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734525

Locations
Brazil
Federal University of Rio de Janeiro Recruiting
Rio de Janeiro, RJ, Brazil, 21941913
Contact: Marcio Nucci, MD    5521-25622463    mnucci@hucff.ufrj.br   
Sub-Investigator: Simone A Nouer, MD         
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
Study Chair: Marcio Nucci, MD Universidade Federal do Rio de Janeiro
  More Information

No publications provided

Responsible Party: Marcio Nucci, MD, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01734525     History of Changes
Other Study ID Numbers: Early Therapy
Study First Received: November 20, 2012
Last Updated: November 26, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal do Rio de Janeiro:
candidemia
intensive care unit
1,3 beta-D-glucan

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Invasive
Candidemia
Mycoses
Fungemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014