- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04786249
Impact of Rapid Screening for COVID-19 in Delocalized Biology in the Emergency Department (DELOCOVID)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Early detection with a sensitive technique of COVID-19 is essential to ensure rapid and appropriate patient management, to contain the epidemic and to better understand the global epidemiology of the virus. This detection will intensify in the coming months due to the start of the school year and university as well as the economic recovery. Until now, laboratory diagnostics have relied primarily on the amplification and detection of viral gene sequences in upper respiratory tract samples performed in a centralized laboratory. A new test (Abbott ID NowTM COVID-19) is available on the market. This test is the first in France to be able to be carried out in a delocalized medical biology examination (DMBE) and makes it possible to return a result in less than 15 min directly in the clinical department. The speed of this technique is based on the use of isothermal gene amplification. The investigators will be the first to evaluate it in France in delocalized biology.
The improvement in diagnostic technique, concomitant with the development of knowledge on the pathophysiology and specific therapies, has been accompanied by better therapeutic management of patients with Covid19. To date, dexamethasone represents the first class of drugs proven to be effective in reducing mortality from COVID-19 in patients with severe disease. Anticoagulant treatment at a prophylactic dose in hospitalized patients or at risk for the severe form, and at a curative dose for severe forms is also the subject of strong recommendations due to the high incidence of venous and arterial thromboembolic events in these patients. It is also recommended that the use of broad-spectrum antibiotics be reserved for patients with radiological abnormalities compatible with bacterial superinfection and / or requiring oxygen therapy greater than or equal to 6 liters / min.
In France, systematic screening for SARS-CoV-2 infection in the emergency room before hospitalization, an operating room, or transfer to another establishment. At GhPSJ, the reference RT-PCR technique Simplexa ™ COVID-19 Direct assay has been used routinely since July 2020 by the microbiology laboratory. It allows a result rendering in a minimum delay of 50 minutes. Since September 7, 2020, the prescription of an RT-PCR is systematically associated with a dedicated computerized questionnaire on the DxCare® software completed by the emergency physician. It collects the reason for prescribing RT-PCR: "diagnostic suspicion", "bed management", "preoperative screening", or "screening for transfer to another establishment"; the patient's lifestyle; the symptomatic or asymptomatic nature and the duration of the symptoms. Since October 22, 2020, the DMBE with the Test ID NowTM COVID-19 has been installed and implemented in the Emergency Department. It is used by the trained and authorized Emergency Nursing team for any patient having a prescription for RT-PCR Sars-CoV-2 by the emergency physician.
The investigators wish to verify the hypothesis that obtaining the rapid diagnosis of Sars-CoV-2 infection by DMBE in the emergency room (Test ID NowTM COVID-19) makes it possible to optimize the organizational and medical management of emergency room patients having a Sars-CoV-2 RT-PCR test. In the literature, there is no study available evaluating the impact of a rapid examination in delocalized biology on the medical management of patients in an emergency department.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Ile De France
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Paris, Ile De France, Francia, 75014
- Groupe Hospitalier Paris Saint-Joseph
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients presenting to the emergency unit of the GhPSJ and for whom a PCR examination is prescribed by the emergency doctor in charge of the patient during the two periods of 7 weeks:
- Period 1 (weeks 37 to 43 of the year 2020): RT PCR SARS-CoV-2 was carried out in the microbiology laboratory
- Period 2 (44 to 50 of the year 2020): diagnosis of SARS-CoV-2 infection with the ID Now ™ technique in emergencies in DMBE with respect for the standards and recommendations of delocalized biology.
The number of patients included will be 1200 per period.
Descripción
Inclusion Criteria:
- Patient aged ≥ 18 years
- Patient presenting to the emergency unit of the GhPSJ and for whom a PCR examination is prescribed by the emergency doctor in charge of the patient
- French-speaking patient
Exclusion Criteria:
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
- Patient objecting to the use of their data for this research.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Retrospectivo
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Evaluate the impact of a short delay in delivering results in delocalized biology on the emergency medical care time, in comparison with the reference method by RT-PCR at the central laboratory of microbiology
Periodo de tiempo: Day 1
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Time of medical care in the emergency department corresponding to the time between the first medical contact (time stamp of the medical observation traced in DxCare®) and the patient's discharge from the Emergency Department (time stamp of the stay in DxCare®)
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Day 1
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Evaluate the impact of the rapid result in DMBE in comparison with the reference method on the final orientation of the patient
Periodo de tiempo: Day 1
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Number of returns home and the number of hospitalizations in conventional services and intensive care.
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Day 1
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Evaluate the impact of the rapid result in DMBE in comparison with the reference method on the bed management
Periodo de tiempo: Day 1
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Number of admissions in single and double rooms
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Day 1
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Evaluate the impact of the rapid result in DMBE in comparison with the reference method on the number of additional examinations carried out and their deadline
Periodo de tiempo: Day 1
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Number of blood tests, ECG, chest X-ray, chest CT scan without injection, pulmonary CT angiography
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Day 1
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Evaluate the impact of the rapid result in DMBE in comparison with the reference method on the prescriptions and the timeframe for the implementation of specific therapies against Covid-19 in hospitalized patients
Periodo de tiempo: Day 1
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Introduction of corticosteroid therapy and anticoagulation
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Day 1
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Evaluate the impact of the rapid result in DMBE in comparison with the reference method on the prescription of antibiotic treatments
Periodo de tiempo: Day 1
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Number of antibiotic treatments
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Day 1
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Compare the primary endpoint for two subgroups of patients according to their treatment schedule
Periodo de tiempo: Day 1
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Number of patients who had a PCR prescription by the day medical team between 8:31 a.m. and 6:30 p.m. and those who had a PCR prescription by the on-call medical team between 6:31 p.m. and 8:30 a.m.
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Day 1
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Evaluate the level of satisfaction and the feelings of the medical and paramedical teams of the Emergency Department regarding the DMBE Test ID Now ™ COVID-19 and its impact
Periodo de tiempo: Day 1
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Staff questionnaire (satisfied or not satisfied)
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Day 1
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jean-Claude NGUYEN, Groupe Hospitalier Paris Saint Joseph
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- Procesos Patológicos
- Infecciones por coronavirus
- Infecciones por coronaviridae
- Infecciones por Nidovirales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones del Tracto Respiratorio
- Enfermedades de las vías respiratorias
- Neumonía Viral
- Neumonía
- Enfermedades pulmonares
- Atributos de la enfermedad
- COVID-19
- Emergencias
Otros números de identificación del estudio
- DELOCOVID
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. .
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