Negative Beta Glucan in ICU Patients

Sponsor
Universidade Federal do Rio de Janeiro (Other)
Overall Status
Completed
CT.gov ID
NCT01734525
Collaborator
(none)
85
1
1
13
6.5

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Nov 1, 2012
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin [30 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Federal University of Rio de Janeiro Rio de Janeiro RJ Brazil 21941913

Sponsors and Collaborators

  • Universidade Federal do Rio de Janeiro

Investigators

  • Study Chair: Marcio Nucci, MD, Universidade Federal do Rio de Janeiro

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marcio Nucci, MD, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01734525
Other Study ID Numbers:
  • Early Therapy
First Posted:
Nov 27, 2012
Last Update Posted:
Jul 8, 2019
Last Verified:
Apr 1, 2019
Keywords provided by Marcio Nucci, MD, Universidade Federal do Rio de Janeiro
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Anidulafungin
Arm/Group Description Patients at risk will receive therapy with anidulafungin Anidulafungin: Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards
Period Title: Overall Study
STARTED 85
COMPLETED 85
NOT COMPLETED 0

Baseline Characteristics

Arm/Group Title Anidulafungin
Arm/Group Description Patients at risk will receive therapy with anidulafungin Anidulafungin: Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards
Overall Participants 85
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
45
52.9%
>=65 years
40
47.1%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]
63
Sex: Female, Male (Count of Participants)
Female
44
51.8%
Male
41
48.2%
Region of Enrollment (participants) [Number]
Brazil
85
100%

Outcome Measures

1. Primary Outcome
Title Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin
Description The main interest is to evaluate the ocurrence of candidemia in patients with negative 1,3 beta-D-glucan who discontinue anidulafungin
Time Frame 30 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Anidulafungin
Arm/Group Description Patients at risk will receive therapy with anidulafungin Anidulafungin: Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards
Measure Participants 21
Candidemia
0
0%
No candidemia
21
24.7%

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title One Arm
Arm/Group Description Patients at risk will receive therapy with anidulafungin Anidulafungin: Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards
All Cause Mortality
One Arm
Affected / at Risk (%) # Events
Total / (NaN)
Serious Adverse Events
One Arm
Affected / at Risk (%) # Events
Total 0/85 (0%)
Other (Not Including Serious) Adverse Events
One Arm
Affected / at Risk (%) # Events
Total 0/85 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Marcio Nucci
Organization Federal University of Rio de Janeiro
Phone 5521-39382463
Email mnucci@hucff.ufrj.br
Responsible Party:
Marcio Nucci, MD, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01734525
Other Study ID Numbers:
  • Early Therapy
First Posted:
Nov 27, 2012
Last Update Posted:
Jul 8, 2019
Last Verified:
Apr 1, 2019