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Negative Beta Glucan in ICU Patients | Clinical Trials | Clareo Health

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COMPLETEDPhase 4NCT01734525

Negative Beta Glucan in 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 ha...

Lead sponsor: Universidade Federal do Rio de Janeiro•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Universidade Federal do Rio de Janeiro

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.

Age

18 - No limit years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 8, 2019Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment85

Start dateNov 2012

Last updatedJul 8, 2019

Condition

Locations shown

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2019Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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