Status:
COMPLETED
Clinical Impact Analysis of PA-100 AST in a Spanish GP Setting
Lead Sponsor:
Sysmex Europe GmbH
Collaborating Sponsors:
Sysmex España S.L.
Conditions:
UTI - Urinary Tract Infection
UTI - Lower Urinary Tract Infection
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 * M...
Detailed Description
Uncomplicated cystitis in females is among the most frequent community-acquired infections. Urinary tract infection (UTI) is classified as uncomplicated if it occurs in patients with a structurally an...
Eligibility Criteria
Inclusion
- 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
- Withdraw of consent
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2025
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT07189429
Start Date
July 1 2024
End Date
August 30 2025
Last Update
September 24 2025
Active Locations (1)
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1
Centro de Salud Ensanche de Vallecas
Madrid, Spain