Serial Therapeutic and Antifungal Monitoring Protocol

NCT02163889 | Completed

• 1 other identifier: PRO-00254
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 3

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.

Conditions

Candidemia

Keywords

Candida; Blood culture; Antifungal therapy; Sepsis

Outcome Measures

Primary Outcomes (1)

• Time to negative test result

  The number of days to a negative test result will be compared between the T2Candida Test and blood culture.

  14 days post enrollment

Study Arms (1)

Candida Positive Patients

Symptomatic adult patients, confirmed via blood culture with species identification to be positive for Candida

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• T2 Biosystems: lead

Study Sites (3)

University of Alabama

Birmingham, Alabama, 35294-2030, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• 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.

  PMID: 29367293 DERIVED

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

MeSH Terms

Conditions

Candidemia; Torulopsis; Sepsis

Condition Hierarchy (Ancestors)

Candidiasis, Invasive; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 16, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 20, 2018

Record last verified: 2015-09

Locations

US (3)