Complicated Urinary Tract InfectionNCT06824129
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
An observational study of Complicated Urinary Tract Infection, run by QIAGEN Gaithersburg, Inc at 1 site in United Kingdom.
Trial summary
Performance evaluation of QIAstat-Dx cUTI Plus AMR Panel using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx cUTI Plus AMR Panel achieves its intended performance during normal conditions of use by the intended user in the intended environment Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complicated Urinary Tract Infection
- How many people
- 1,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Dec 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with signs and symptoms of complicated urine infection
Who may be able to join
- Specimens from subjects of all ages and demographic characteristics can be enrolled.
- Specimen must come from patients with suspected cUTI by their healthcare provider:
- Urine specimen with evidence of pyuria confirmed by positive urine analysis (Dipstick analysis positive for leukocyte esterase or at least 10 White Blood Cells percubic millimeter) And
- A sign or symptom of a cUTI (for example: chills or rigors or warmth associated with fever, malaise, flank pain or pelvic pain and/or costo-vertebral angle pain or tenderness on physical examination, nausea or vomiting, dysuria, urinary frequency or urinary urgency)
- Specimen must be residual leftover and de-identified
- Specimen obtained preserved (containing boric acid, sodium formate or sodium borate) or unpreserved as midstream urine or fresh urine catheter
Show all 11Show fewer
- For Preserved Only: Fresh prospectively collected preserved specimens stored to up 48 hours at 15°C-25°C or 24 hours at 2°C-8°C.
- For Unpreserved Only: Fresh prospectively collected unpreserved specimens stored up to 24 hours at 2°C-8°C.
- Specimen must have a minimum of 3 ml of urine available.
- Specimen date of collection and standard of Care testing results should be available.
- Specimen must be unique (only one sample enrolled per patient).
Who cannot join
- Specimens enrolled in the study may be excluded for the following reasons:
- Lack of clear subject identification or label on urine specimen.
- Specimen has been centrifuged.
- Obvious physical damage of residual specimen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR Panel on Patients Suspected of Complicated Urinary Tract Infection
Performance evaluation of QIAstat-Dx cUTI Plus AMR Panel using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx cUTI Plus AMR Panel achieves its intended performance during normal conditions of use by the intended user in the intended environment
Read the detailed description
The objective of the study is to demonstrate that the QIAstat-Dx cUTI Plus AMR Panel achieves its intended performance during normal conditions of use by the intended user in the intended environment.
The primary objective is to evaluate the performance of QIAstat-Dx cUTI Plus AMR Panel in comparison with the results obtained from the reference method.
The secondary objective of the study is to evaluate the safety ofQIAstat-Dx cUTI Plus AMR Panel with respect to users/operators.
The primary study endpoint will be the results for each analyte obtained from testing prospective specimens with QIAstat-Dx cUTI Plus AMR Panel and Reference Method. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be determined
- Conditions
- Complicated Urinary Tract Infection
- Keywords
- QIAstat-Dx, Clinical Performance Study, complicated Urinary infection
What is being measured
The primary outcome is the main question the study is designed to answer.
PPA
Positive percent agreement
Measured: 8 months
NPA
Negative percent agreement
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start23 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Urinary Tract 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QIAGEN Gaithersburg, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Johnson, Principal investigator, Qiagen Manchester Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824129
- Sponsor's protocol ID
- DHF-19-0598-0-CSP-001
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR Panel on Patients Suspected of Complicated Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT06824129
- Acronym / sponsor ID
- DHF-19-0598-0-CSP-001
- Conditions
- Complicated Urinary Tract Infection
- Keywords
- QIAstat-Dx, Clinical Performance Study, complicated Urinary infection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- QIAGEN Gaithersburg, IncIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Feb 2025 (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.
Performance evaluation of QIAstat-Dx cUTI Plus AMR Panel using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx cUTI Plus AMR Panel achieves its intended performance during normal conditions of use by the intended user in the intended environment
Detailed description
The objective of the study is to demonstrate that the QIAstat-Dx cUTI Plus AMR Panel achieves its intended performance during normal conditions of use by the intended user in the intended environment.
The primary objective is to evaluate the performance of QIAstat-Dx cUTI Plus AMR Panel in comparison with the results obtained from the reference method.
The secondary objective of the study is to evaluate the safety ofQIAstat-Dx cUTI Plus AMR Panel with respect to users/operators.
The primary study endpoint will be the results for each analyte obtained from testing prospective specimens with QIAstat-Dx cUTI Plus AMR Panel and Reference Method. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be determined
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with signs and symptoms of complicated urine infection
Key inclusion criteria (11 listed)
- Specimens from subjects of all ages and demographic characteristics can be enrolled.
Key exclusion criteria (4 listed)
- Specimens enrolled in the study may be excluded for the following reasons:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PPA
Time frame: 8 months
Positive percent agreement
NPA
Time frame: 8 months
Negative percent agreement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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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.
Sarah Johnson principal investigator
Qiagen Manchester Limited
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 Complicated Urinary Tract Infection, run by QIAGEN Gaithersburg, Inc at 1 site in United Kingdom.
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 11 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
PPA (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.