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

NCT04076436 | Unknown

• 1 other identifier: FIS-FOS-2019-01
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Prospective follow-up study; Real-life conditions; Complicated urinary tract infection; Escherichia coli infection; Fosfomycin efficacy; Quinolones; Beta-lactams; Microbiological failure; Resistance development

Outcome Measures

Primary Outcomes (3)

• The difference in the proportion of subjects getting clinical-microbiological cure on the test of cure between the fosfomycin cohort and the quinolones or beta-lactams cohort

  The difference in the proportion of subjects getting clinical-microbiological cure (disappearance of all new symptoms or signs related to urinary infection and negative uroculture) on the test of cure between the fosfomycin cohort and the quinolones or beta-lactams cohort

  21 days

• The proportion of microbiological failure on the test of cure in the fosfomycin cohort (measured as isolation of Escherichia coli in uroculture on the test of cure).

  The proportion of microbiological failure on the test of cure in the fosfomycin cohort (measured as isolation of Escherichia coli in uroculture on the test of cure).

  21 days

• The proportion of development of resistance (or decrease in sensitivity) to fosfomycin during or after treatment: Presence of mutation in genes uhpT, uhpA, uhpB, uhpC, uhpT, crp, cyaA, ptsl and fosA and measure CMI.

  The proportion of development of resistance (or decrease in sensitivity) to fosfomycin during or after treatment: Presence of mutation in genes uhpT, uhpA, uhpB, uhpC, uhpT, crp, cyaA, ptsl and fosA and measure CMI.

  30 days

Secondary Outcomes (2)

• To evaluate the frequency of microbiological failure and development of resistance (or decrease in sensitivity) in Escherichia coli isolates.

  30 days

• The difference in the proportion of solicited EAs in subjects in fosfomycin cohort and quinolones or beta-lactams cohort.

  Day 5 through Day 21

Study Arms (2)

Fosfomycin cohort:

Cohort of patients with complicated urinary tract infection caused by Escherichia coli treated with intravenous fosfomycin

Other: Drug: Intravenous fosfomycin

Quinolones or beta-lactams cohort

Cohort of patients with complicated urinary tract infection caused by Escherichia coli treated with intravenous quinolones or beta-lactams.

Other: Drug: Intravenous quinolone or beta-lactam

Interventions

Drug: Intravenous fosfomycin OTHER

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

Fosfomycin cohort:

Drug: Intravenous quinolone or beta-lactam OTHER

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

Quinolones or beta-lactams cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with complicated urinary tract infection

You may not qualify if:

• Control cohort (objective 1):

Sponsors & Collaborators

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

Study Sites (2)

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

NOT YET RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

MeSH Terms

Conditions

Escherichia coli Infections

Interventions

beta-Lactams

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Belén Gutiérrez Gutiérrez

  Hospital Universitario Virgen Macarena

  STUDY DIRECTOR

Central Study Contacts

Belén Gutiérrez Gutiérrez

CONTACT

955 00 80 00; belengutiguti@hotmail.com

Elisa Moreno Mellado

CONTACT

955 00 80 00; elisamoreno500@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: September 3, 2019
• Study Start: October 21, 2019
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: November 14, 2019

Record last verified: 2019-08

Locations

ES (2)