- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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
Tutkimuksen yleiskatsaus
Tila
Opintotyyppi
Ilmoittautuminen (Odotettu)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Nancy, Ranska, 54000
- Rekrytointi
- Baux
-
Ottaa yhteyttä:
- Elisabeth Baux, MD
- Puhelinnumero: +33 03 83 15 28 65
- Sähköposti: e.baux@chru-nancy.fr
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Number of dead patients
Aikaikkuna: During Length of stay in intensive care unit (an average of 2 weeks)
|
All cause of mortality
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Demographic data relating to age
Aikaikkuna: Baseline
|
age
|
Baseline
|
|
Demographic data relating to sex
Aikaikkuna: Baseline
|
sex
|
Baseline
|
|
Respiratory failure
Aikaikkuna: Baseline
|
PaO2/iFO2 value
|
Baseline
|
|
Demographic data relating to immunosuppression
Aikaikkuna: Baseline
|
Amount of polynuclear neutrophils (G/L)
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
Aikaikkuna: Baseline
|
hospitalization
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
Aikaikkuna: Baseline
|
dialysis
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
Aikaikkuna: Baseline
|
surgery
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
Aikaikkuna: Baseline
|
presence of percutaneous or long-term catheter
|
Baseline
|
|
Clinical data relating to pre-admission antibiotics
Aikaikkuna: Baseline
|
type of antibiotic prescribed
|
Baseline
|
|
Clinical data in the initial phase relating to SAPS 2 score
Aikaikkuna: Baseline
|
Simplified acute Physiology score (SAPS2) score between 0 and 163 and a predicted mortality between 0% and 100%
|
Baseline
|
|
Clinical data in the initial phase relating to SOFA admission
Aikaikkuna: Baseline
|
Sequential Organ Failure Assessment (SOFA)
|
Baseline
|
|
Clinical data in the initial phase relating to neutropenia
Aikaikkuna: 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)
|
|
Clinical data in the initial phase relating to neutropenia
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: During Length of stay in intensive care unit (an average of 2 weeks)
|
oxygen dependence
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to hyperthermia
Aikaikkuna: During Length of stay in intensive care unit (an average of 2 weeks)
|
hyperthermia
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to chills
Aikaikkuna: During Length of stay in intensive care unit (an average of 2 weeks)
|
chills
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to headhache
Aikaikkuna: During Length of stay in intensive care unit (an average of 2 weeks)
|
headache
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to productive cough
Aikaikkuna: During Length of stay in intensive care unit (an average of 2 weeks)
|
productive cough
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to dyspnoea
Aikaikkuna: During Length of stay in intensive care unit (an average of 2 weeks)
|
dyspnoea
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to acute respiratory failure
Aikaikkuna: 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
Aikaikkuna: 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)
|
|
Clinical data in the initial phase relating to uni - or multi - lobar infiltration on chest X - ray or CT scan
Aikaikkuna: During Length of stay in intensive care unit (an average of 2 weeks)
|
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)
|
|
Clinical data in the initial phase relating to pleural effusion
Aikaikkuna: 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
Aikaikkuna: During Length of stay in intensive care unit (an average of 2 weeks)
|
necrotizing pneumonitis
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to renal failure
Aikaikkuna: During Length of stay in intensive care unit (an average of 2 weeks)
|
renal failure according to KDIGO classification
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Prognostic factors for this pathology
Aikaikkuna: During Length of stay in intensive care unit (an average of 2 weeks)
|
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
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Complications
Aikaikkuna: 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 ...
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Collection of infectious samples
Aikaikkuna: During Length of stay in intensive care unit (an average of 2 weeks)
|
Bacteriological, Parasitological, Virological
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Probabilistic antibiotherapy
Aikaikkuna: 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)
|
|
Probabilistic antibiotherapy
Aikaikkuna: 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)
|
|
Prescribed antibiotic therapy
Aikaikkuna: During Length of stay in intensive care unit (an average of 2 weeks)
|
Collection of Prescribed antibiotic therapy
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Prescribed antibiotic therapy
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: During Length of stay in intensive care unit (an average of 2 weeks)
|
Number of patients with Influenza type A
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Number of patients with Influenza type B
Aikaikkuna: During Length of stay in intensive care unit (an average of 2 weeks)
|
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
Aikaikkuna: 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)
|
|
Dosage of antiviral treatment
Aikaikkuna: 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)
|
|
Number of serious influenza infections per year and per center with early and late deaths
Aikaikkuna: During Length of stay in intensive care unit (an average of 2 weeks)
|
Mortality caused by serious inflenza infections
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- RNA-virusinfektiot
- Virussairaudet
- Infektiot
- Hengitysteiden infektiot
- Hengityselinten sairaudet
- Keuhkosairaudet
- Bakteeri-infektiot
- Bakteeri-infektiot ja mykoosit
- Gram-positiiviset bakteeri-infektiot
- Orthomyxoviridae -infektiot
- Keuhkokuume
- Influenssa, ihminen
- Keuhkokuume, bakteeri
- Stafylokokki-infektiot
- Keuhkokuume, stafylokokki
Muut tutkimustunnusnumerot
- RNI2017/FLUVALENTINE-BAUX/YB
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .