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Search / Trial NCT04076436

Efficacy of Intravenous Fosfomycin in the Treatment of Complicated Urinary in Real-life Conditions.

Launched by FUNDACIÓN PÚBLICA ANDALUZA PARA LA GESTIÓN DE LA INVESTIGACIÓN EN SEVILLA · Aug 30, 2019

Trial Information

Current as of June 24, 2025

Unknown status

Keywords

Prospective Follow Up Study Real Life Conditions Complicated Urinary Tract Infection Escherichia Coli Infection Fosfomycin Efficacy Quinolones Beta Lactams Microbiological Failure Resistance Development

ClinConnect Summary

The objectives are:

1. To asses the clinical and microbiological efficacy and safety of intravenous fosfomycin in the treatment of complicated urinary tract infections due to Escherichia coli in real life conditions, in comparison with a matched cohort of patients treated with quinolones or beta-lactams.
2. To evaluate the frequency of microbiological failure and development of resistance (or decrease in sensitivity) in Escherichia coli isolates, depending on different pharmacokinetic and pharmacodynamic parameters, with special emphasis on fAUC0-24/MIC.
3. To evaluate the frequency of mic...

Gender

ALL

Eligibility criteria

  • Fosfomycin cohort:
  • Inclusion criteria: Patients over 18 years of age. Patients who have started treatment with intravenous fosfomycin, estimated that they will require at least 2 days of treatment with fosfomycin, initiated as either as empirical treatment (within 24 hours after the emergency visit or onset of symptoms) or targeted treatment (within 24 hours of the availability of the antibiogram).
  • Exclusion criteria: Patients under 18 years of age. Patients in palliative treatment.
  • Control cohort (objective 1):
  • Inclusion criteria:Patients over 18 years of age. Patients who have started treatment with intravenous quinolones or beta-lactams, estimated that they will require at least 2 days of treatment with the drug, initiated as either as empirical treatment (within 24 hours after the emergency visit or onset of symptoms) or targeted treatment (within 24 hours of the availability of the antibiogram). Each patient from the fosfomycin cohort will be matched with a patient from this control cohort according to their.
  • Exclusion criteria: Patients under 18 years of age.Patients in palliative treatment; Informed consent not signed by the patient.

About Fundación Pública Andaluza Para La Gestión De La Investigación En Sevilla

The Fundación Pública Andaluza para la Gestión de la Investigación en Sevilla is a public foundation dedicated to advancing clinical research and innovation within the Andalusian healthcare system. By fostering collaboration among healthcare professionals, researchers, and institutions, the foundation aims to enhance the quality and efficiency of clinical trials. With a strong focus on ethical standards and regulatory compliance, it plays a pivotal role in supporting the development of new therapies and improving patient outcomes in the region. Through its commitment to scientific excellence and community health, the foundation contributes significantly to the advancement of medical knowledge and practice.

Locations

Córdoba, , Spain

Sevilla, , Spain

Patients applied

0 patients applied

Trial Officials

Belén Gutiérrez Gutiérrez

Study Director

Hospital Universitario Virgen Macarena

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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