- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03367624
Epidemiology of Post-influenza Bacterial Pneumonia Due to a Panton-Valentine Leukocidin Positive Staphylococcus Aureus (FLUVALENTINE)
Secondary bacterial influenza pneumonia caused by Panton-Valentine Leukocidin Positive Staphylococcus aureus is a rare complication but with poor prognosis. This pathology seems to affect young patients (20-40 years) without any medical history. Since the influenza pandemic of 2009, this complication is more and more mentioned, sought and diagnosed. However, the literature is poor, consisting of case reports, experimental studies on murine models, and low-power studies.
The main objective is to evaluate the mortality in intensive care units of patients post-influenza bacterial pneumonia due to a Panton-Valentine Leukocidin positive Staphylococcus aureus
연구 개요
상태
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Nancy, 프랑스, 54000
- 모병
- Baux
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연락하다:
- Elisabeth Baux, MD
- 전화번호: +33 03 83 15 28 65
- 이메일: e.baux@chru-nancy.fr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patient treated for post-influenza bacterial pneumonia due to a Panton-Valentine Leukocidin positive Staphylococcus aureus in intensive care unit
Exclusion Criteria:
- Minor patient
- Patient under protective measurement
- Absence of bacteriological and / or virological documentation
공부 계획
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디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of dead patients
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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All cause of mortality
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During Length of stay in intensive care unit (an average of 2 weeks)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Demographic data relating to age
기간: Baseline
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age
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Baseline
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Demographic data relating to sex
기간: Baseline
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sex
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Baseline
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Respiratory failure
기간: Baseline
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PaO2/iFO2 value
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Baseline
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Demographic data relating to immunosuppression
기간: Baseline
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Amount of polynuclear neutrophils (G/L)
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Baseline
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risk factors for methicillin-resistant Staphylococcus aureus
기간: Baseline
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hospitalization
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Baseline
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risk factors for methicillin-resistant Staphylococcus aureus
기간: Baseline
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dialysis
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Baseline
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risk factors for methicillin-resistant Staphylococcus aureus
기간: Baseline
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surgery
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Baseline
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risk factors for methicillin-resistant Staphylococcus aureus
기간: Baseline
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presence of percutaneous or long-term catheter
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Baseline
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Clinical data relating to pre-admission antibiotics
기간: Baseline
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type of antibiotic prescribed
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Baseline
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Clinical data in the initial phase relating to SAPS 2 score
기간: Baseline
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Simplified acute Physiology score (SAPS2) score between 0 and 163 and a predicted mortality between 0% and 100%
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Baseline
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Clinical data in the initial phase relating to SOFA admission
기간: Baseline
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Sequential Organ Failure Assessment (SOFA)
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Baseline
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Clinical data in the initial phase relating to neutropenia
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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neutropenia
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to neutropenia
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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thrombocytopenia
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to metabolic acidosis
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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metabolic acidosis
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to oxygen dependence
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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oxygen dependence
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to hyperthermia
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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hyperthermia
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to chills
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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chills
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to headhache
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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headache
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to productive cough
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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productive cough
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to dyspnoea
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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dyspnoea
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to acute respiratory failure
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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acute respiratory failure
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to hemoptysis
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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hemoptysis
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to uni - or multi - lobar infiltration on chest X - ray or CT scan
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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uni - or multi - lobar infiltration on chest X - ray or CT scan
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to pleural effusion
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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pleural effusion
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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necrotizing pneumonitis
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to renal failure
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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renal failure according to KDIGO classification
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During Length of stay in intensive care unit (an average of 2 weeks)
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Prognostic factors for this pathology
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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Time to diagnosis of influenza infection and Panton-Valentine Leukocidin Positive Staphylococcus aureus Haemoptysis, leukopenia, thrombocytopenia, acute respiratory distress syndrome (ARDS), PaO2 / Fi02, inotropic support
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During Length of stay in intensive care unit (an average of 2 weeks)
|
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Complications
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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Complications related to Septic shock ARDS: according to Berlin 2009 classification Extra corporeal vein-venous or veino-arterial oxygenation membrane (ECMO VV or ECMO VA) Ischemic limb Pneumothorax Acute renal failure according to Kdigo classification Disseminated intravascular coagulation (DIC) (2) Cardiogenic shock / cardiogenic pulmonary acute edema Multi visceral failure syndrome (3) Use of surgery: abscess drainage, lobectomy, amputation, laparotomy and colonic resection ...
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During Length of stay in intensive care unit (an average of 2 weeks)
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Collection of infectious samples
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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Bacteriological, Parasitological, Virological
|
During Length of stay in intensive care unit (an average of 2 weeks)
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Probabilistic antibiotherapy
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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Collection of probabilistic antibiotherapy
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During Length of stay in intensive care unit (an average of 2 weeks)
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Probabilistic antibiotherapy
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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Duration of probabilistic antibiotherapy
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During Length of stay in intensive care unit (an average of 2 weeks)
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Prescribed antibiotic therapy
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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Collection of Prescribed antibiotic therapy
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During Length of stay in intensive care unit (an average of 2 weeks)
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Prescribed antibiotic therapy
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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Duration for the appropriate anti-toxin treatment
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During Length of stay in intensive care unit (an average of 2 weeks)
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Collection of the date of introduction of adapted antibiotic therapy
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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Collection of the date of introduction of adapted antibiotic therapy
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During Length of stay in intensive care unit (an average of 2 weeks)
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Number of patients with Influenza type A
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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Number of patients with Influenza type A
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During Length of stay in intensive care unit (an average of 2 weeks)
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Number of patients with Influenza type B
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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Number of patients with Influenza type B
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During Length of stay in intensive care unit (an average of 2 weeks)
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Date of initiation of anti-viral treatment in relation to the onset of symptoms and duration of anti-viral treatment
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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Date of initiation of anti-viral treatment in relation to the onset of symptoms and duration of anti-viral treatment
|
During Length of stay in intensive care unit (an average of 2 weeks)
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Dosage of antiviral treatment
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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Dosage of antiviral treatment
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During Length of stay in intensive care unit (an average of 2 weeks)
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Number of serious influenza infections per year and per center with early and late deaths
기간: During Length of stay in intensive care unit (an average of 2 weeks)
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Mortality caused by serious inflenza infections
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During Length of stay in intensive care unit (an average of 2 weeks)
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (예상)
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
- RNI2017/FLUVALENTINE-BAUX/YB
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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