Serial Therapeutic and Antifungal Monitoring Protocol



Status:Completed
Healthy:No
Age Range:18 - 95
Updated:8/22/2018
Start Date:September 2014
End Date:April 2017

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The objective of this study is to investigate T2Candida performance as a monitoring tool for
post-therapy clearance of Candida compared to blood culture.

This study will collect a T2clinical specimen and companion blood culture from patients who
have exhibited a positive blood culture by gram stain for yeast, and who are receiving
treatment with antifungal therapy.

One blood culture and one set of T2clinical specimens will be collected at specified
intervals to monitor the clearance of Candida infection from the bloodstream.

Each T2 result will be compared to the companion blood culture result. The comparison will
determine if the presence of antifungal therapy inhibits blood culture and leads to an
incidence of blood culture false negative test results. The T2 result, which is not impacted
by the presence of antifungal therapy, can show that the pathogen is still present for some
additional period of time.

Inclusion Criteria:

- Subject or subject's authorized representative must be able to understand, read and
sign the study specific informed consent form after the nature of the study has been
fully explained to them.

- Subject is between 18-95 years of age

- Subject has a blood culture result that is positive for yeast within 36 hours of
enrollment

Exclusion Criteria:

- Subject has other co-morbid condition(s) that, in the opinion of the Investigator,
could limit the subject's ability to participate in the study or impact the scientific
integrity of the study

- All T2 Bio individual clinical research specimens contain < 3 ml of blood

- Use of any novel (i.e. not commercially available) drug compound within 30 days prior
to the collection of T2 Bio blood specimens.
We found this trial at
3
sites
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Eleftherios Mylonakis, MD
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Cornelius Clancy, MD
Phone: 412-648-6553
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Birmingham, Alabama 35294
Principal Investigator: Peter Pappas, MD
Phone: 205-996-4108
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Birmingham, AL
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