NCT03367624

Brief 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. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2017

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

December 11, 2017

Status Verified

November 1, 2017

Enrollment Period

19 days

First QC Date

November 18, 2017

Last Update Submit

December 4, 2017

Conditions

Keywords

influenzaStaphylococcus AureusPneumoniaPV leukocidinICU

Outcome Measures

Primary Outcomes (1)

  • Number of dead patients

    All cause of mortality

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

Secondary Outcomes (39)

  • Demographic data relating to age

    Baseline

  • Demographic data relating to sex

    Baseline

  • Respiratory failure

    Baseline

  • Demographic data relating to immunosuppression

    Baseline

  • risk factors for methicillin-resistant Staphylococcus aureus

    Baseline

  • +34 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baux

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Influenza, HumanPneumonia, StaphylococcalStaphylococcal InfectionsPneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesPneumonia, BacterialLung Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2017

First Posted

December 11, 2017

Study Start

October 1, 2017

Primary Completion

October 20, 2017

Study Completion

March 1, 2018

Last Updated

December 11, 2017

Record last verified: 2017-11

Locations