Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05681156

Enrollment

199

Registered

2023-01-12

Start date

2023-02-01

Completion date

2023-09-08

Last updated

2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Legionella Pneumophila Serogroup 1 Infection, Streptococcus Pneumoniae Infection

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.

Interventions

OTHERN/A- There is no intervention.

There is no intervention.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026