Impact of eradication of asymptomatic bacteriuria on reducing the incidence of early infection in patients with periprosthetic femoral fractures requiring hip hemiarthroplasty

Phase 1

• Conditions: Early infection in patients with periprosthetic femoral fracture; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-001108-47-ES
• Lead Sponsor: Fundació Hospital Universitari Vall Hebron-Institut de Recerca (VHIR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-20
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1394

Inclusion Criteria

1. Age ?18 years.
2.Femur fracture patients diagnosed at the participating centers, requiring hip hemiarthroplasty.
3.Properly informed and give their written consent to participate in the study and undergo tests and examinations that entails.
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 1394
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1394

Exclusion Criteria

1.Febrile patients (axillary temperature> 38 ° C).
2.Patients with sugestive symptoms of active urinary tract infection (urinary tract symptoms, macroscopic evidence of pyuria).
3.Patients with any active infectious process requiring administration of antibiotic therapy.
4.Patients who had not been possible the collection of a urine sample to take a urine culture.
5.Patients with a history of intolerance or allergic fosfomycin-trometamol.
6.Impossibility for patients with oral intake.
7.Expectation of life less than 3 months.

Study & Design

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