Serial Therapeutic and Antifungal Monitoring Protocol

Completed

Conditions studied: Candidemia

In brief

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.

Key facts

Study ID

NCT02163889

Run by

T2 Biosystems

People needed

31

Starts

2014-09-01

Expected to finish

2017-04-01

Last updated by the study team

2018-08-20

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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