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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status

Unknown

Conditions

Complicated Urinary Tract Infection

Treatments

Other: Drug: Intravenous fosfomycin

Other: Drug: Intravenous quinolone or beta-lactam

Study type

Observational

Funder types

Other

Identifiers

NCT04076436

FIS-FOS-2019-01

Details and patient eligibility

About

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).

Full description

The objectives are:

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.
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.
To evaluate the frequency of microbiological failure and development of resistance (or decrease in sensitivity) and their association with the existence of basal mutations in genes related to intracellular transport or regulation of these transporters.

For objective 1, a study of prospective mated cohorts (fosfomycin cohort versus quinolones or beta-lactams cohort) will be performed, and for objectives 2 and 3 a prospective cohort study (fosfomycin cohort) will be conducted.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.