Serial Therapeutic and Antifungal Monitoring Protocol

Completed

• Conditions: Candidemia

• Registration Number: NCT02163889
• Lead Sponsor: T2 Biosystems

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-16
• Study Start: 2014-09
• Status Verified: 2015-09
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to negative test result	14 days post enrollment	The number of days to a negative test result will be compared between the T2Candida Test and blood culture.

Trial Locations

Locations (3)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States