- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07559318
Post-Emergency Optimization of Antibiotic Therapy for Urinary Tract Infection (UTI) (REVIU48)
Post-Emergency Optimization of UTI Antibiotic Therapy: "Fluoroquinolones and Third-Generation Cephalosporins Under the Spotlight"
Prospective, multicenter, non-interventional study conducted over 6 months, including patients presenting to the emergency department with suspected urinary tract infection managed as outpatients and discharged with or without empiric antibiotic therapy.
Discharge antibiotic prescriptions are reviewed, with subsequent reassessment and optimization of treatment based on urine culture and susceptibility results
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Urinary tract infections are a frequent cause of emergency department visits, accounting for substantial antibiotic use. Data from the OSCOUR (Organisation de la Surveillance Coordonnée des Urgences) network estimate around 5,000 weekly visits. Resistance rates among Enterobacteriaceae in urine samples are particularly high, largely driven by the widespread use of broad-spectrum antibiotics, especially fluoroquinolones, which are commonly prescribed as empiric therapy. Given their potential for serious adverse effects and their strong selective pressure for resistance, stricter control of their use is warranted, yet remains insufficient.
In current emergency practice, conditions such as pyelonephritis or male urinary tract infections are often treated with broad-spectrum antibiotics that are continued even when pathogens are susceptible to narrower agents. De-escalation to narrower-spectrum therapies would help preserve the microbiota and limit resistance.
This study is a prospective, multicenter, non-interventional observational study conducted over 6 months. It includes patients presenting to the emergency department with suspected urinary tract infections managed on an outpatient basis and discharged with or without empiric antibiotic therapy. Antibiotic treatments are reassessed 48 - 72 hours after inclusion by a physician, allowing for patient follow-up and potential modification of the initial prescription based on urine culture and susceptibility results, in accordance with current guidelines.
The study aims to assess the value of this reassessment strategy in improving antimicrobial stewardship for urinary tract infections in emergency settings and to inform future optimization of clinical practices.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Anna BELKACEM, MD
- Número de teléfono: 01 43 86 21 62
- Correo electrónico: anna.belkacem@chiv.fr
Copia de seguridad de contactos de estudio
- Nombre: Wissem TOUADI, Resident
- Correo electrónico: wissemtouadi@gmail.com
Ubicaciones de estudio
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Melun, Francia
- Aún no reclutando
- GHSIF
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Contacto:
- De Pontfarcy, MD
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Saint-Denis, Francia
- Aún no reclutando
- CH St denis
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Contacto:
- SAYRE, MD
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Villeneuve-Saint-Georges, Francia
- Reclutamiento
- CHIV
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Contacto:
- Anna BELKACEM, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age 18 years or over
- Patients presenting at emergency department, with symptoms suggestive of a urinary tract infection suitable for outpatient management (uncomplicated cystitis or cystitis at risk of complications, uncomplicated pyelonephritis or pyelonephritis at risk of complications, male urinary tract infection with or without fever) who have had a urine culture taken
Exclusion Criteria:
- Refusal to participate in the study
- Vulnerable person (person under guardianship or trusteeship, minor, person deprived of liberty, person unable to express their refusal)
- Pregnant women
- Severe urinary tract infection (sepsis, septic shock or requiring drainage, except for low urinary catheterisation)
- Hospitalisation for a urinary tract infection or decompensation of another comorbidity
- Suspected urinary tract infection without a urine culture having been performed
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Suspected of outpatient urinary tract infection
Inclusion of patients with outpatient urinary tract infection in emergency department
|
Re assessment of antibiotic therapy at 48 hours based on urine culture results : discontinuation or de-escalation to a narrower-spectrum agent
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Assess changes in fluoroquinolone and third-generation cephalosporin prescribing in outpatient urinary tract infections following adjustment based on urine culture and susceptibility results.
Periodo de tiempo: At 48 hours - 72 hours after the patient inclusion
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At 48 hours - 72 hours after the patient inclusion
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Incidence (percentage) of adverse effects associated with antibiotics.
Periodo de tiempo: At 1 month after the consultation in the Emergency department
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At 1 month after the consultation in the Emergency department
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Incidence (percentage) of antibiotic prescription savings in the Emergency department for outpatient urinary tract infections (cessation of prescription, shortening of treatment duration and/or narrowing of the spectrum) following the intervention
Periodo de tiempo: At 48 hours - 72 hours after the patient inclusion
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At 48 hours - 72 hours after the patient inclusion
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Assessment of patient satisfaction with medical follow-up via a question asked directly to the patient via a questionnaire (Better if more than 50 percent of patients are satisfied)
Periodo de tiempo: At 1 month after the consultation in the Emergency department
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At 1 month after the consultation in the Emergency department
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Assessment of patients' knowledge of antibiotic resistance via a question asked directly to the patient via a questionnaire (Better if more than 50 percent of patients are satisfied)
Periodo de tiempo: At 1 month after the consultation in the Emergency department
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At 1 month after the consultation in the Emergency department
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Atributos de la enfermedad
- Infecciones
- Enfermedades contagiosas
- Condiciones Patológicas, Signos y Síntomas
- Infecciones del tracto urinario
- Enfermedades Transmisibles Emergentes
Otros números de identificación del estudio
- REVIU48
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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