Clinical trial NCT02163889: Serial Therapeutic and Antifungal Monitoring Protocol
Official title: Serial Therapeutic and Antifungal Monitoring Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candidemia
Keywords: Candida
Blood culture
Antifungal therapy
Sepsis
Lead sponsor: T2 Biosystems
Sponsor class: INDUSTRY
First posted: 2014-06-16
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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.

Primary outcomes:
measure: Time to negative test result
timeFrame: 14 days post enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
References:
citation: Mylonakis E, Zacharioudakis IM, Clancy CJ, Nguyen MH, Pappas PG. Efficacy of T2 Magnetic Resonance Assay in Monitoring Candidemia after Initiation of Antifungal Therapy: the Serial Therapeutic and Antifungal Monitoring Protocol (STAMP) Trial. J Clin Microbiol. 2018 Mar 26;56(4):e01756-17. doi: 10.1128/JCM.01756-17. Print 2018 Apr.