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

NCT07189429 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2025-09-24

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

PA-100 AST

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

Sponsors & Collaborators

  • Sysmex España S.L.

    collaborator INDUSTRY

  • Sysmex Europe GmbH

    lead INDUSTRY

Principal Investigators

  • Jose Medina Polo · Urología, Hospital 12 de Octubre. Servicio Madrileño de salud

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-06-30
Completion
2025-08-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07189429 on ClinicalTrials.gov