STAMP: Serial Therapeutic and Antifungal Monitoring Protocol

Sponsor

T2 Biosystems (Industry)

Overall Status

Completed

CT.gov ID

NCT02163889

Collaborator

(none)

Enrollment

Locations

Actual Duration (Months)

10.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Candidemia

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 Design

Study Type:

Observational

Actual Enrollment :

31 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Serial Therapeutic and Antifungal Monitoring Protocol

Actual Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Candida Positive Patients Symptomatic adult patients, confirmed via blood culture with species identification to be positive for Candida

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294-2030
2	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
3	Rhode Island Hospital	Providence	Rhode Island	United States	02903