- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Typ studiów
Zapisy (Oczekiwany)
Kontakty i lokalizacje
Lokalizacje studiów
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Nancy, Francja, 54000
- Rekrutacyjny
- Baux
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Kontakt:
- Elisabeth Baux, MD
- Numer telefonu: +33 03 83 15 28 65
- E-mail: e.baux@chru-nancy.fr
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of dead patients
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Demographic data relating to age
Ramy czasowe: Baseline
|
age
|
Baseline
|
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Demographic data relating to sex
Ramy czasowe: Baseline
|
sex
|
Baseline
|
|
Respiratory failure
Ramy czasowe: Baseline
|
PaO2/iFO2 value
|
Baseline
|
|
Demographic data relating to immunosuppression
Ramy czasowe: Baseline
|
Amount of polynuclear neutrophils (G/L)
|
Baseline
|
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risk factors for methicillin-resistant Staphylococcus aureus
Ramy czasowe: Baseline
|
hospitalization
|
Baseline
|
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risk factors for methicillin-resistant Staphylococcus aureus
Ramy czasowe: Baseline
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dialysis
|
Baseline
|
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risk factors for methicillin-resistant Staphylococcus aureus
Ramy czasowe: Baseline
|
surgery
|
Baseline
|
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risk factors for methicillin-resistant Staphylococcus aureus
Ramy czasowe: Baseline
|
presence of percutaneous or long-term catheter
|
Baseline
|
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Clinical data relating to pre-admission antibiotics
Ramy czasowe: Baseline
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type of antibiotic prescribed
|
Baseline
|
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Clinical data in the initial phase relating to SAPS 2 score
Ramy czasowe: 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
Ramy czasowe: Baseline
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Sequential Organ Failure Assessment (SOFA)
|
Baseline
|
|
Clinical data in the initial phase relating to neutropenia
Ramy czasowe: During Length of stay in intensive care unit (an average of 2 weeks)
|
neutropenia
|
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
Ramy czasowe: During Length of stay in intensive care unit (an average of 2 weeks)
|
thrombocytopenia
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to metabolic acidosis
Ramy czasowe: During Length of stay in intensive care unit (an average of 2 weeks)
|
metabolic acidosis
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to oxygen dependence
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: During Length of stay in intensive care unit (an average of 2 weeks)
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dyspnoea
|
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
Ramy czasowe: During Length of stay in intensive care unit (an average of 2 weeks)
|
acute respiratory failure
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to hemoptysis
Ramy czasowe: During Length of stay in intensive care unit (an average of 2 weeks)
|
hemoptysis
|
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
Ramy czasowe: 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
|
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
Ramy czasowe: During Length of stay in intensive care unit (an average of 2 weeks)
|
pleural effusion
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase
Ramy czasowe: 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
Ramy czasowe: During Length of stay in intensive care unit (an average of 2 weeks)
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renal failure according to KDIGO classification
|
During Length of stay in intensive care unit (an average of 2 weeks)
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Prognostic factors for this pathology
Ramy czasowe: 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
Ramy czasowe: During Length of stay in intensive care unit (an average of 2 weeks)
|
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
Ramy czasowe: 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)
|
|
Probabilistic antibiotherapy
Ramy czasowe: During Length of stay in intensive care unit (an average of 2 weeks)
|
Collection of probabilistic antibiotherapy
|
During Length of stay in intensive care unit (an average of 2 weeks)
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|
Probabilistic antibiotherapy
Ramy czasowe: During Length of stay in intensive care unit (an average of 2 weeks)
|
Duration of probabilistic antibiotherapy
|
During Length of stay in intensive care unit (an average of 2 weeks)
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Prescribed antibiotic therapy
Ramy czasowe: During Length of stay in intensive care unit (an average of 2 weeks)
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Collection of Prescribed antibiotic therapy
|
During Length of stay in intensive care unit (an average of 2 weeks)
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|
Prescribed antibiotic therapy
Ramy czasowe: During Length of stay in intensive care unit (an average of 2 weeks)
|
Duration for the appropriate anti-toxin treatment
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Collection of the date of introduction of adapted antibiotic therapy
Ramy czasowe: During Length of stay in intensive care unit (an average of 2 weeks)
|
Collection of the date of introduction of adapted antibiotic therapy
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Number of patients with Influenza type A
Ramy czasowe: 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
Ramy czasowe: During Length of stay in intensive care unit (an average of 2 weeks)
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Number of patients with Influenza type B
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Date of initiation of anti-viral treatment in relation to the onset of symptoms and duration of anti-viral treatment
Ramy czasowe: During Length of stay in intensive care unit (an average of 2 weeks)
|
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
Ramy czasowe: During Length of stay in intensive care unit (an average of 2 weeks)
|
Dosage of antiviral treatment
|
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
Ramy czasowe: 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)
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zakażenia wirusem RNA
- Choroby wirusowe
- Infekcje
- Infekcje dróg oddechowych
- Choroby Układu Oddechowego
- Choroby płuc
- Infekcje bakteryjne
- Infekcje bakteryjne i grzybice
- Zakażenia bakteriami Gram-dodatnimi
- Infekcje Orthomyxoviridae
- Zapalenie płuc
- Grypa, człowiek
- Zapalenie płuc, bakteryjne
- Infekcje gronkowcowe
- Zapalenie płuc, Staphylococcus
Inne numery identyfikacyjne badania
- RNI2017/FLUVALENTINE-BAUX/YB
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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