E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Early infection in patients with periprosthetic femoral fracture |
Infección periprotésica precoz en pacientes con fractura de Femur |
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E.1.1.1 | Medical condition in easily understood language |
Early infection in patients with periprosthetic femoral fracture |
Infección periprotésica precoz en pacientes con fractura de Femur |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Evaluar el impacto clínico de la erradicación de la bacteriuria asintomática (BA) sobre la reducción de la incidencia de infección periprotésica (IPP) precoz en pacientes con fractura de fémur que requieren una hemiartroplastia de cadera (HAC). |
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E.2.2 | Secondary objectives of the trial |
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. |
1.Describir la prevalencia de BA en pacientes sometidos a una HAC por fractura de fémur. 2.Evaluar la incidencia de IPP en los primeros 3 meses posteriores al implante de la HAC. 3. Analizar si la presencia de BA se asocia a un mayor riesgo de IPP en estos pacientes en comparación con los pacientes sometidos a una HAC que no tienen BA. 4.Evaluar el impacto de de una estrategia de intervención basada en el tratamiento empírico de la BA en los pacientes con fractura de fémur susceptibles de ser tratados con una HAC en cuanto a la reducción de la incidencia de IPP precoz. 5.Evaluar la seguridad de la pauta de tratamiento antibiótico indicada para erradicar la BA. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
1.Edad ?18 años. 2.Pacientes con fractura de fémur, diagnosticados en los centros participantes, que requieran una HAC. 3.Adecuadamente informados y que otorguen su consentimiento por escrito para participar en el estudio y someterse a las pruebas y exploraciones que ello comporta. |
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E.4 | Principal 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. |
1.Pacientes febriles (Temperatura axilar >38ºC). 2.Pacientes con sintomatología sugestiva de infección urinaria activa (síndrome miccional, evidencia macroscópica de piuria). 3.Pacientes con cualquier proceso infeccioso activo que requiera la administración de un tratamiento antibiótico. 4.Pacientes en los que no haya sido posible la recogida de una muestra de orina para cursar un urocultivo. 5.Pacientes con historia de alérgica o intolerancia a fosfomicina-trometamol. 6.Pacientes con imposibilidad para la ingesta oral. 7.Expectativa de vida inferior a 3 meses. |
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E.5 End points |
E.5.1 | 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) |
Incidencia acumulada de IPP tras la implementación de una estrategia de intervención de erradicación de la BA (administración de una dosis única de fosfomicina-trometamol) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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). |
1.Duración de la hospitalización 2.Microorganismo identificado en el urocultivo (si aplica) y patrón de sensibilidad 3.Procesos infecciosos intercurrentes durante el ingreso hospitalario 4.Otras complicaciones posquirúrgicas ortopédicas 5.Re-ingreso debido a la IPP 6.Microorganismo identificado en supuesto de IPP (si aplica) y patrón de sensibilidad 7.Necesidad de re-intervención (por la IPP o por cualquier motivo ortopédico que afecte a dicha articulación por luxación o inestabilidad de la HAC). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
practica habitual |
medical practice |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
última visita del último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |