- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07703852
Pilot Study to Study the Time Between Pleuropulmonary Ultrasound and Antibiotic Therapy Prescription in Patients Admitted to the Emergency Department for Suspected Pneumonia (PRE-EPPA)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The study will be conducted in the Emergency Department of grenoble University Hospital.
Patient admitted to the emergency department for respiratory symptoms (cough, fever, and/or dyspnea) will be enrolled in the study according to the inclusion and non-inclusion criteria and after obtaining his consent.
The investigator will perform the pleuropulmonary ultrasound following the clinical examination carried out by the physician in charge of the patient.
The patient's care is unaffected by the pleuropulmonary ultrasound's outcome, which is unknown to the physician in charge of the patient.
Data collection after the patient's discharge from the emergency department.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Alice GREMBER, MD
- Número de teléfono: 0033476766784
- Correo electrónico: AGrember@chu-grenoble.fr
Copia de seguridad de contactos de estudio
- Nombre: Marcelline BUFFIN
- Número de teléfono: 0033476766784
- Correo electrónico: Mbuffin@chu-grenoble.fr
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:
- Patient over 18 years admitted the the emergency department of Grenoble Alpes University Hospital with respiratory symptoms (cough and/or dyspnea, fever).
- No objection by the subject to the study
- Affiliated to the french social security system (or equivalent)
Exclusion Criteria:
- Patient admitted to a life-threatening emergency
- Patient already on antibiotic therapy on admission
- Patient excluded from another study
- Patient with respiratory signs following chest trauma
- Unable to communicate or non-french speaking patients or those with impaired comprehension or consciousness
- Protected persons referred to in articles L1121-6 and L1121-8 of French public health code (deprived of liberty, tutorship or curatorship)
- The patient already enrolled in the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Patient admitted for suspicion of Pneumonia
Patient admitted in emergency department of Grenoble Alpes University Hospital for suspicion of Pneumonia
|
In addition to the traditional management done by the physician at the patient's expense (such as clinical examination and paraclinical examinations like biology, chest X-ray, etc.), the investigator will perform pleuropulmonary ultrasound.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time between the antibiotic prescription and the pleuropulmonary ultrasonography used to detect pneumonia
Periodo de tiempo: 1 hour
|
Time between the antibiotic prescription and the pleuropulmonary ultrasonography used to detect pneumonia
|
1 hour
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Calculation of the predictive values of the pleuropulmonary ultrasound for pneumonia diagnosis
Periodo de tiempo: 1 day
|
Calculation of the predictive values of the pleuropulmonary ultrasound for pneumonia diagnosis: area under the curve, sensitivity, specificity, positive predictive value, negative predictive value.
|
1 day
|
|
duration of performing the pleuropulmonary ultrasound
Periodo de tiempo: 5 minutes
|
duration of performing the pleuropulmonary ultrasound
|
5 minutes
|
|
Time between the patient's admission to the emergency department and the completion of the pleuropulmonary ultrasound
Periodo de tiempo: 1 hour
|
Time between the patient's admission to the emergency department and the completion of the pleuropulmonary ultrasound
|
1 hour
|
|
4. Time between the performance of the pleuropulmonary ultrasound and the performance of the chest X-ray
Periodo de tiempo: 2 hours
|
4. Time between the performance of the pleuropulmonary ultrasound and the performance of the chest X-ray
|
2 hours
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Alice GREMBER, MD, University Hospital, Grenoble
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Otros números de identificación del estudio
- 38RC26.0148
- IDRCB :2026-A00930-51 (Otro identificador: CPP NORD OUEST IV (French Ethics Committees))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. The minimum anonymized source data for performing the statistical analysis will be made public at the time of publication, with the article, or deposited in an appropriate public database. Other anonymized data may be available from the principal investigator upon reasonable request and with the consent of the sponsor.
In accordance with the French law n ° 2002-303 of March 4th, 2002, the subjects can be informed, at their request, of the overall results of the research. In this study, the investigators commit to individually communicating the overall results to each subject participating in the research by a short (popularized) summary and associated with a copy of the scientific article.
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .