Early infection in patients with periprosthetic femoral fracture
Conditions
Interventions
Product Name: fosfomycin
Pharmaceutical Form: Granules for oral solution
INN or Proposed INN: FOSFOMYCIN TROMETAMOL
CAS Number: 23155-02-4
Concentration unit: g gram(s)
Concentration type: equal
Conce
Sponsors
Fundació Hospital Universitari Vall Hebron-Institut de Recerca (VHIR)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the clinical impact of eradication of asymptomatic bacteriuria on reducing the incidence of early periprosthetic infection in patients with femur fracture requiring hip hemiarthroplasty.;Secondary Objective: 1.Describe the prevalence of asymptomatic bacteriuria in patients undergoing hip hemiarthroplasty fracture femur. 2.To evaluate the incidence of early periprosthetic infection in the first 3 months after implantation of hip hemiarthroplasty. 3.Analyze if the presence of asymptomatic bacteriuria is associated to a higher risk of early periprosthetic infection in these patients compared with patients undergoing hip hemiarthroplasty who have asymptomatic bacteriuria. 4.To evaluate the impact of an intervention strategy based on the empirical treatment of asymptomatic bacteriuria in patients with femoral fractures that can be treated with a hip hemiarthroplasty in terms of reducing the incidence of early periprosthetic infection. 5.Assess the safety of the antibiotic treatment regimen indicated to eradicate asymptomatic bacteriuria.;Primary end point(s): Cumulative incidence of early periprosthetic infection after the implementation of an intervention strategy for the eradication of asymptomatic bacteriuria (administration of a single dose of fosfomycin-trometamol);Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Length of hospitalization 2.Microorganism identified in the urine culture (if applicable) and sensitivity pattern. 3.intercurrent infectious processes during hospitalization. 4.Other post orthopedic surgical complications. 5.Readmission due to early periprosthetic infection. 6.Microorganism identified in course of early periprosthetic infection(if applicable) and sensitivity pattern. 7.Reoperation (for early periprosthetic infection or any orthopedic reason affecting such articulation dislocation or instability of hip hemiarthroplasty).;Timepoint(s) of evaluation of this end point: 3 months | — |
Countries
Spain
Contacts
Public ContactInmaculada Fuentes
Unitat de Suport a la Investigació Clinica (USIC)
Outcome results
None listed