Serial Therapeutic and Antifungal Monitoring Protocol

Candidemia Clinical Trial

— STAMP  

Official title:

Serial Therapeutic and Antifungal Monitoring Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163889
• Other study ID #: PRO-00254
• Status: Completed
• Start date: September 2014
• Est. completion date: April 2017

Study information

• Verified date: September 2015
• Source: T2 Biosystems
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Candidemia

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
T2 Biosystems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to negative test result	The number of days to a negative test result will be compared between the T2Candida Test and blood culture.	14 days post enrollment