CompletedNot Applicable

QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study

United Kingdom2,142 participantsStarted 2023-12-01

Plain-language summary

Study for performance evaluation of the QIAstat-Dx® BCID Plus AMR GPF-Panel and the QIAstat Dx® BCID Plus AMR GN-Panel in comparison with other chosen comparator methods

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Positive (as identified through Gram stain) blood culture media specimens cultured within bottle types listed in IFU. * Residual and de-identified specimens. * Specimen from subject who has not previously been enrolled. * Fresh prospectively collected specimens tested within 24 hours of initial blood culture bottle positivity. * Frozen prospectively collected specimens frozen within 24 hours of initial blood culture bottle positivity. * Minimum 1.5 mL volume available * In stage 2 - Pure colony isolates of Bacilli, Actinobacteria, fungi (except Fusarium), Enterobacterales, Pseudomondales, Nesseriales, Pasteurellales, Bacterioidales, or Xanthomonadales. Exclusion Criteria: * Positive Blood Culture specimens inoculated with a sample type other than Blood (i.e. Paracentesis, or other body fluids) * Specimens collected off-label from the manufacturer's package insert (e.g., less than the minimum required blood volume was collected). * Frozen specimens which are unable to be cultured after thawing. * Specimen from subject previously enrolled

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PPA

Timeframe: 6 moths

NPA

Timeframe: 6 moths

Trial details

NCT IDNCT05305534

SponsorQIAGEN Gaithersburg, Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-04-10

View on ClinicalTrials.gov More Blood Disease trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.