Clinical Impact Analysis of PA-100 AST in a Spanish GP Setting

NCT07189429 | Completed

• 1 other identifier: SEU-MSD-PA100II
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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
• 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

Conditions

UTI - Urinary Tract Infection; UTI - Lower Urinary Tract Infection; AMR; Cystitis Acute; Cystitis Bacterial

Keywords

Clinical impact investigation; PA-100 AST

Outcome Measures

Primary Outcomes (1)

• Frequency of antibiotic prescription

  At initial GP visit

Secondary Outcomes (1)

• Type of antibiotic prescribed

  At initial GP visit

Study Arms (2)

Standard of Care

NO INTERVENTION

Patients were managed according to local guidelines for uncomplicated community acquired urinary tract infection

Standard of Care with PA.100 AST

EXPERIMENTAL

Patients were managed according to local guidelines for uncomplicated community acquired urinary tract infection while having the additional information of PA-100 AST available during treatment decision.

Diagnostic Test: PA-100 AST

Interventions

PA-100 AST DIAGNOSTIC_TEST

Results of the PA-100 AST were made available to the treating physician

Standard of Care with PA.100 AST

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Withdraw of consent

Sponsors & Collaborators

• Sysmex Europe GmbH: lead
• Sysmex España S.L.: collaborator

Study Sites (1)

Centro de Salud Ensanche de Vallecas

Madrid, Spain

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jose Medina Polo

  Urología, Hospital 12 de Octubre. Servicio Madrileño de salud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 24, 2025
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 30, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)