Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol

Completed

• Conditions: Streptococcus Pneumoniae Infection; Legionella Pneumophila Serogroup 1 Infection

• Registration Number: NCT05681156
• Lead Sponsor: Meridian Bioscience, Inc.

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2022-12-27
• Study First Posted: 2023-01-12
• Study Start: 2023-02-01
• Primary Completion: 2023-03-23
• Study Completion: 2023-09-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Agreement between Curian S. pneumo/Legionella Assay and two cleared FDA assays	7 months	Curian S. pneumo/Legionella Assay will be compared to the comparator assays (both FDA cleared)

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States