Clinical Impact Analysis of PA-100 AST in a Spanish GP Setting (NCT07189429) | Clinical Trial Compass
CompletedNot Applicable
Clinical Impact Analysis of PA-100 AST in a Spanish GP Setting
Spain199 participantsStarted 2024-07-01
Plain-language summary
Assessment of workflow implications of the PA-100 AST System.
Using well-defined data collection protocols, the study comprises the following:
* Collection of clean-catch midstream urine samples
* Measurement of specimens on the PA-100 AST System
o Antibiotics tested: Amoxicillin/clavulanic acid (AMC), Ciprofloxacin (CIP), Trimethoprim (TRI), Fosfomycin (FOS) and Nitrofurantoin (NIT)
* Treatment of patients according to the results of the tests on the PA-100 AST System
* Collection of data about patient treatment and antibiotic prescription when the PA-100 AST System is not used (study baseline)
* Collection of patient related information
* Collection of workflow-related information, including doctors and nurses at the test location
* Evaluation of changes in the prescription behaviour when using the PA-100 AST System, compared to current practice at the Test Location
Who can participate
Age range
18 Years
Sex
FEMALE
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:
Patients were recruited according to the following criteria: non-pregnant female, \>18 years old, presenting with acute UTI symptoms that had been present for \< 7 days (symptoms according to the current guidelines \[EAU\]), with no antibiotic treatment within the previous 7 days, positive urine dipstick for leukocyte esterase (LEU) and/or nitrites (NIT) and who provided a clean-catch mid-stream urine sample.
Exclusion Criteria:
Withdraw of consent
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.