Serial Therapeutic and Antifungal Monitoring Protocol (STAMP)

T2 Biosystems

Status: Completed

Conditions: Candidemia

Study type: Observational

Funder types: Industry

Identifiers

NCT02163889

PRO-00254

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No 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.

Trial design

31 participants in 1 patient group

Candida Positive Patients

Description:

Symptomatic adult patients, confirmed via blood culture with species identification to be positive for Candida