Prospective Study Into the Performance of the MicroPhage S. Aureus/MSSA/MRSA Test Direct From Blo… (NCT01184339) | Clinical Trial Compass
CompletedNot Applicable
Prospective Study Into the Performance of the MicroPhage S. Aureus/MSSA/MRSA Test Direct From Blood Culture Positives
1,165 participantsStarted 2009-08
Plain-language summary
Direct in-vitro identification of S. aureus, methicillin-sensitive S. aureus (MSSA), and methicillin-resistant S. aureus (MRSA) from positive blood cultures by MicroPhage's bacteriophage-based diagnostic platform, two gold-standard reference methods, and two predicate devices with similar indications for use.
Who can participate
Age range
18 Years
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:
* Blood culture positive samples from subjects aged 18+, with any of the following bottle types:
* BD Bactec Standard Aerobic and Anaerobic,
* BD Bactec Plus Aerobic and Anaerobic,
* Completion of the MicroPhage test protocol on the sample.
Exclusion Criteria:
* Samples from subjects under 18 years of age,
* Samples from any other not included bottle types,
* Samples from blood culture positives over 24 hours from alarm,
* Samples deemed contaminated,
* Mislabeled / misidentified samples or data without documented corrections,
* Violations and/or deviations from the MicroPhage test protocol and/or other included test protocols under study.
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
1
Determination of the performance of the MicroPhage S. aureus/ MSSA/MRSA Test for identification of S. aureus and determination of MRSA and MSSA direct from clinical blood culture positives against gold standard laboratory tests.
Timeframe: Daily per device protocol
2
Determination of comparative performance of the MicroPhage S. aureus/MRSA/MSSA Test to the Oxoid PBP2a for determination of MRSA.
Timeframe: Daily per device protocol
3
Determination of the performance of the MicroPhage S. aureus/ MSSA/MRSA Test for identification of S. aureus and determination of MRSA and MSSA direct from clinical blood culture positives against gold standard laboratory tests.