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

NCT04076436 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2019-11-14

No results posted yet for this study

Summary

This will be a prospective observational multicentre study in real-life conditions of patients with complicated urinary infection of community presentation caused by Escherichia coli using intravenous fosfomycin, quinolones or beta-lactams.

It's a multicenter and multinational study and it will include 200 patients in the fosfomycin cohort and 200 patients in the control cohort (quinolones or beta-lactams).

Conditions

  • Complicated Urinary Tract Infection

Interventions

OTHER

Drug: Intravenous fosfomycin

Patients will be visited on days 1 (Day of the urine and blood culture taking), 2, 5, 7, 14, on the test of cure and on day 30. Visit on day 1: First day of treatment. Basal data collection. Visit on day 2: Blood collection to fosfomycin levels calculation. Visits on days 5, 7, 14, on the test of cure (day 21): Clinical evolution data, Urocultures and Adverse effects. Visit on day 30: Assess mortality

OTHER

Drug: Intravenous quinolone or beta-lactam

Patients will be visited on days 1 (Day of the urine and blood culture taking), 5, 7, 14, on the test of cure and on day 30. Visit on day 1: First day of treatment. Basal data collection. Visits on days 5, 7, 14, on the test of cure (day 21): Clinical evolution data, Urocultures and Adverse effects. Visit on day 30: Assess mortality

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Belén Gutiérrez Gutiérrez · Hospital Universitario Virgen Macarena

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-21
Primary Completion
2021-06-30
Completion
2021-12-31

Countries

  • Spain

Study Locations

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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 NCT04076436 on ClinicalTrials.gov