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OpenTrials
Completed

NCT Number: NCT02163889

Serial Therapeutic and Antifungal Monitoring Protocol

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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

T2 Biosystems

Industry

Registry information

Acronym: STAMP

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 16, 2014
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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