Streptococcus Pneumoniae InfectionNCT05681156
Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol
An observational study of Streptococcus Pneumoniae Infection and Legionella Pneumophila Serogroup 1 Infection, run by Meridian Bioscience, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Streptococcus Pneumoniae Infection, Legionella Pneumophila Serogroup 1 Infection
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 8 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients arriving at hospital with suspected pneumonia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- N/A- There is no intervention.
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N/A- There is no intervention.Other
There is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: N/A- There is no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Feb 2023
- Primary completion23 Mar 2023
- Study completion8 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Streptococcus Pneumoniae InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681156
- Sponsor's protocol ID
- CLIN0015
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2022
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: No plan yet
Publications
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.
PubMed 35953247Schimmel 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.
PubMed 31587039
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT05681156
- Acronym / sponsor ID
- CLIN0015
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected pneumonia | – | Other: N/A- There is no intervention.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients arriving at hospital with suspected pneumonia
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N/A- There is no intervention.There is no intervention. | Other | Patients with suspected pneumonia |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Background: PubMed 35953247Yasuo 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.
- Background: PubMed 31587039Schimmel 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.
- Individual participant dataSharing planned: Undecided. No plan yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcus Pneumoniae Infection and Legionella Pneumophila Serogroup 1 Infection, run by Meridian Bioscience, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between Curian S. pneumo/Legionella Assay and two cleared FDA assays (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05681156, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.