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COMPLETEDNCT05681156

Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol

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 ...

Lead sponsor: Meridian Bioscience, Inc.•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Meridian Bioscience, Inc.

This study will evaluate the preliminary clinical performance of the RUO Curian S. pneumo/Legionella assay against two FDA cleared comparators for its use in the qualitative detection of Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 antigens in human urine specimens.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Adult males and females, with symptom of pneumonia and for whom a Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 diagnostic test has been ordered by a practicing physician.
•At least 2mL of urine from fresh de-identified clinical specimen from standard of care lab testing
•Only one (1) specimen per patient will be included in the study
•Materials used within their expiration date
•Storage time and conditions within requested indications listed on RUO Package Insert

Exclusion Criteria

•Specimens from patients for whom a Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 diagnostic test has not been ordered
•Storage times and conditions that exceed these study protocol requirements listed on RUO Package Insert
•Urine samples provided in unsatisfactory conditions

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 29, 2025Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment199

Start dateFeb 2023

Last updatedJan 29, 2025

Condition

Streptococcus Pneumoniae Infection Legionella Pneumophila Serogroup 1 Infection

Locations shown

Indiana University

Indianapolis, Indiana

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2025Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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