- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04786249
Impact of Rapid Screening for COVID-19 in Delocalized Biology in the Emergency Department (DELOCOVID)
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ile De France
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Paris, Ile De France, 프랑스, 75014
- Groupe Hospitalier Paris Saint-Joseph
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 회고전
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Evaluate the impact of the rapid result in DMBE in comparison with the reference method on the final orientation of the patient
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Day 1
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Staff questionnaire (satisfied or not satisfied)
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Day 1
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jean-Claude NGUYEN, Groupe Hospitalier Paris Saint Joseph
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- DELOCOVID
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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