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Completed

NCT Number: NCT05681156

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 serogroup 1 antigens in human urine specimens.

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Key information

Conditions

Streptococcus Pneumoniae Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Legionella Pneumophila Serogroup 1 Infection Pneumococcal Infections Streptococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N/A- There is no intervention.

Other

There is no intervention.

Primary outcomes

  1. Agreement between Curian S. pneumo/Legionella Assay and two cleared FDA assays

    Time frame: 7 months

    Curian S. pneumo/Legionella Assay will be compared to the comparator assays (both FDA cleared)

Sponsors and collaborators

Lead sponsor

Meridian Bioscience, Inc.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2023
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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