Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol
NCT05681156 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 199
Last updated 2025-01-29
Summary
Beta trial to evaluate the preliminary clinical performance of the Curian S. pneumo/Legionella assay for its use in the qualitative detection of Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 antigens in human urine specimens.
Conditions
- Streptococcus Pneumoniae Infection
- Legionella Pneumophila Serogroup 1 Infection
Interventions
- OTHER
-
N/A- There is no intervention.
There is no intervention.
Sponsors & Collaborators
-
Meridian Bioscience, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-01
- Primary Completion
- 2023-03-23
- Completion
- 2023-09-08
- FDA Device
- Yes
Countries
- United States
Study Locations
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