Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol

NCT05681156 | Completed FDA Device

• 1 other identifier: CLIN0015
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Streptococcus Pneumoniae Infection; Legionella Pneumophila Serogroup 1 Infection

Outcome Measures

Primary Outcomes (1)

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

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

  7 months

Study Arms (1)

Patients with suspected pneumonia

Leftover de-identified samples from standard of care will be taken from patients suspected of having pneumonia due to Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 infection.

Other: N/A- There is no intervention.

Interventions

N/A- There is no intervention. OTHER

There is no intervention.

Patients with suspected pneumonia

Eligibility Criteria

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

Study Population

All patients arriving at hospital with suspected pneumonia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

• Yasuo S, Murata M, Nakagawa N, Kawasaki T, Yoshida T, Ando K, Okamori S, Okada Y; Japanese ARDS clinical practice guideline systematic review task force. Diagnostic accuracy of urinary antigen tests for pneumococcal pneumonia among patients with acute respiratory failure suspected pneumonia: a systematic review and meta-analysis. BMJ Open. 2022 Aug 11;12(8):e057216. doi: 10.1136/bmjopen-2021-057216.

  PMID: 35953247 BACKGROUND

• Schimmel JJ, Haessler S, Imrey P, Lindenauer PK, Richter SS, Yu PC, Rothberg MB. Pneumococcal Urinary Antigen Testing in United States Hospitals: A Missed Opportunity for Antimicrobial Stewardship. Clin Infect Dis. 2020 Sep 12;71(6):1427-1434. doi: 10.1093/cid/ciz983.

  PMID: 31587039 BACKGROUND

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

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

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 12, 2023
• Study Start: February 1, 2023
• Primary Completion: March 23, 2023
• Study Completion: September 8, 2023
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

US (1)