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Serial Therapeutic and Antifungal Monitoring Protocol (STAMP)

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ClinicalTrials.gov Identifier: NCT02163889
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
T2 Biosystems

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.


Condition or disease
Candidemia

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.

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Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Group/Cohort
Candida Positive Patients
Symptomatic adult patients, confirmed via blood culture with species identification to be positive for Candida



Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
At each time point, three 4 ml whole blood specimens will be collected. One sample will be tested, and the remaining samples will be available for use in investigating discrepant T2Candida assay and blood culture results, or may be used for research purposes


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients receiving treatment with antifungal therapy for 1 of 5 Candida species:

  • Candida albicans
  • Candida tropicalis
  • Candida glabrata
  • Candida parapsolosis
  • Candida krusei
Criteria

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.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
T2 Biosystems
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: T2 Biosystems
ClinicalTrials.gov Identifier: NCT02163889    
Other Study ID Numbers: PRO-00254
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: September 2015
Keywords provided by T2 Biosystems:
Candida
Blood culture
Antifungal therapy
Sepsis
Additional relevant MeSH terms:
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Candidemia
Fungemia
Sepsis
Infection
Candidiasis, Invasive
Candidiasis
Mycoses
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes