Serial Therapeutic and Antifungal Monitoring Protocol (STAMP)

August 17, 2018 updated by: T2 Biosystems

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-2030
        • University of Alabama
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

T2 Biosystems

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2014

Primary Completion (ACTUAL)

April 1, 2017

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (ESTIMATE)

June 16, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2018

Last Update Submitted That Met QC Criteria

August 17, 2018

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-00254

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Candidemia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe