Serial Therapeutic and Antifungal Monitoring Protocol (STAMP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02163889|
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : August 20, 2018
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|
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 Type :||Observational|
|Actual Enrollment :||31 participants|
|Official Title:||Serial Therapeutic and Antifungal Monitoring Protocol|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2017|
Candida Positive Patients
Symptomatic adult patients, confirmed via blood culture with species identification to be positive for Candida
- Time to negative test result [ Time Frame: 14 days post enrollment ]The number of days to a negative test result will be compared between the T2Candida Test and blood culture.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163889
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35294-2030|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|