Serial Therapeutic and Antifungal Monitoring Protocol

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02163889

Acronym

STAMP

Enrollment

Registered

2014-06-16

Start date

2014-09-30

Completion date

2017-04-30

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidemia

Keywords

Candida, Blood culture, Antifungal therapy, Sepsis

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results