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InfluenzaFLUVALENTINENCT03367624

Epidemiology of Post-influenza Bacterial Pneumonia Due to a Panton-Valentine Leukocidin Positive Staphylococcus Aureus

An observational study of Influenza and Staphylococcus Aureus Pneumonia, run by Central Hospital, Nancy, France at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
35 participants
Where
1 siteFrance
Study dates
1 Oct 2017to Mar 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients hospitalized in intensive care units for the management of influenza pneumonia infected with Panton-Valentine Leukocidin Positive Staphylococcus aureus over a retrospective period from 2009 to winter 2016-2017.

Who may be able to join

  • Patient treated for post-influenza bacterial pneumonia due to a Panton-Valentine Leukocidin positive Staphylococcus aureus in intensive care unit

Who cannot join

  • Minor patient
  • Patient under protective measurement
  • Absence of bacteriological and / or virological documentation

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting

  • Baux

    Nancy, 54000

    Elisabeth Baux, MD, 03 83 15 28 65 ext. +33, e.baux@chru-nancy.fr

    Recruiting

Other trials in France

About this study

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

Keywords
influenza, Staphylococcus Aureus, Pneumonia, PV leukocidin, ICU
Medical subject headings
Influenza, Human, Pneumonia, Staphylococcal, Staphylococcal Infections, Pneumonia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of dead patients

    All cause of mortality

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

Secondary outcomes (39)

  1. Demographic data relating to age

    age

    Measured: Baseline

  2. Demographic data relating to sex

    sex

    Measured: Baseline

  3. Respiratory failure

    PaO2/iFO2 value

    Measured: Baseline

  4. Demographic data relating to immunosuppression

    Amount of polynuclear neutrophils (G/L)

    Measured: Baseline

  5. risk factors for methicillin-resistant Staphylococcus aureus

    hospitalization

    Measured: Baseline

  6. risk factors for methicillin-resistant Staphylococcus aureus

    dialysis

    Measured: Baseline

  7. risk factors for methicillin-resistant Staphylococcus aureus

    surgery

    Measured: Baseline

  8. risk factors for methicillin-resistant Staphylococcus aureus

    presence of percutaneous or long-term catheter

    Measured: Baseline

  9. Clinical data relating to pre-admission antibiotics

    type of antibiotic prescribed

    Measured: Baseline

  10. Clinical data in the initial phase relating to SAPS 2 score

    Simplified acute Physiology score (SAPS2) score between 0 and 163 and a predicted mortality between 0% and 100%

    Measured: Baseline

  11. Clinical data in the initial phase relating to SOFA admission

    Sequential Organ Failure Assessment (SOFA)

    Measured: Baseline

  12. Clinical data in the initial phase relating to neutropenia

    neutropenia

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  13. Clinical data in the initial phase relating to neutropenia

    thrombocytopenia

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  14. Clinical data in the initial phase relating to metabolic acidosis

    metabolic acidosis

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  15. Clinical data in the initial phase relating to oxygen dependence

    oxygen dependence

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  16. Clinical data in the initial phase relating to hyperthermia

    hyperthermia

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  17. Clinical data in the initial phase relating to chills

    chills

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  18. Clinical data in the initial phase relating to headhache

    headache

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  19. Clinical data in the initial phase relating to productive cough

    productive cough

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  20. Clinical data in the initial phase relating to dyspnoea

    dyspnoea

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  21. Clinical data in the initial phase relating to acute respiratory failure

    acute respiratory failure

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  22. Clinical data in the initial phase relating to hemoptysis

    hemoptysis

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  23. Clinical data in the initial phase relating to uni - or multi - lobar infiltration on chest X - ray or CT scan

    uni - or multi - lobar infiltration on chest X - ray or CT scan

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  24. Clinical data in the initial phase relating to pleural effusion

    pleural effusion

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  25. Clinical data in the initial phase

    necrotizing pneumonitis

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  26. Clinical data in the initial phase relating to renal failure

    renal failure according to KDIGO classification

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  27. Prognostic factors for this pathology

    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

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  28. Complications

    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 ...

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  29. Collection of infectious samples

    Bacteriological, Parasitological, Virological

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  30. Probabilistic antibiotherapy

    Collection of probabilistic antibiotherapy

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  31. Probabilistic antibiotherapy

    Duration of probabilistic antibiotherapy

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  32. Prescribed antibiotic therapy

    Collection of Prescribed antibiotic therapy

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  33. Prescribed antibiotic therapy

    Duration for the appropriate anti-toxin treatment

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  34. Collection of the date of introduction of adapted antibiotic therapy

    Collection of the date of introduction of adapted antibiotic therapy

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  35. Number of patients with Influenza type A

    Number of patients with Influenza type A

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  36. Number of patients with Influenza type B

    Number of patients with Influenza type B

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  37. Date of initiation of anti-viral treatment in relation to the onset of symptoms and duration of anti-viral treatment

    Date of initiation of anti-viral treatment in relation to the onset of symptoms and duration of anti-viral treatment

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  38. Dosage of antiviral treatment

    Dosage of antiviral treatment

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

  39. Number of serious influenza infections per year and per center with early and late deaths

    Mortality caused by serious inflenza infections

    Measured: During Length of stay in intensive care unit (an average of 2 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2017
  2. Study start1 Oct 2017
  3. Primary completion20 Oct 2017
  4. Study completionMar 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03367624
Sponsor's protocol ID
RNI2017/FLUVALENTINE-BAUX/YB
Acronym
FLUVALENTINE
Status last verified
Nov 2017
First submitted
18 Nov 2017
Last updated
11 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Influenza and Staphylococcus Aureus Pneumonia, run by Central Hospital, Nancy, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of dead patients (time frame: During Length of stay in intensive care unit (an average of 2 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03367624.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.

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