Clinical study to evaluate the efficacy of fosfomycin vs meropenem in the treatment of bacteremia due to Escherichia coli (general infection caused by a specific bacteria).

Phase 1

• Conditions: Bacteremic urinary tract infection by Escherichia coli extended spectrum beta-lactamase (ESBL).; MedDRA version: 16.1 Level: PT Classification code 10052238 Term: Escherichia urinary tract infection System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-002922-21-ES
• Lead Sponsor: FISEVI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-18
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 198

Inclusion Criteria

* Adult (over 18) hospitalized patients diagnosed with bacteremia due to urinary tract infection by E. coli extended spectrum beta-lactamase (ESBL).
*Isolation of this microorganism in blood culture with clinical sepsis without other obvious or the most likely origin of the urinary bacteremia.
*Required intravenous treatment during 5 days at least.
*Women of childbearing potential must have a negative pregnancy test.
*Signed informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

*Polymicrobial bacteremia.
*Undrained renal abscess or not resolved urinary tract obstruction.
*Prostatitis.
*Haematogenous or contiguous urinary infection
*Concomitant infections
*Polycystic kidney disease.
*Renal trasplantation.
*Allergy or hypersensitivity to fosfomycin or meropenem.
*Terminal condition, or life expectancy less than 90 days, or palliative treatment of the underlying disease.
*Delayed inclusion > 12 hours since the identification of E. coli ESBL in blood culture.
*Patients participating in other clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified