NCT02523885

Brief Summary

To investigate exposure to nonsteroidal antiinflammatory drugs (NSAIDs) during outpatient management at the early stage of community-acquired pneumonia (CAP) requiring hospital consultation. Non-interventional observational study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
181

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

4 active sites

Status
completed

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

November 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

August 13, 2015

Last Update Submit

February 25, 2016

Conditions

Community-acquired Pneumonia

Keywords

Pneumonia, Bacterial [C01.252.620]Bronchopneumonia [C08.381.677.127]Pleuropneumonia [C08.730.610.473]Anti-Inflammatory Agents, Non-Steroidal

Outcome Measures

Primary Outcomes (1)

  • binary composite primary endpoint

    presence or absence of one or more of the following : occurrence of at least one pneumonia-related complication; need for ICU admission; prolonged length of hospital stay. pneumonia-related complications include: worsening of hypoxemia; need for mechanical ventilation; occurrence or increase of pleural effusion; empyema; occurrence of septic shock;

    28 days

Secondary Outcomes (5)

  • pneumonia severity index

    2 days

  • CURB score at inclusion

    2 days

  • duration of antimicrobial therapy

    28 days

  • occurence of a nosocomial infection

    28 days

  • 28-day mortality

    28 days

Other Outcomes (1)

  • chest pain

    2 days

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all adult patient presenting either to the emergency department or admitted directly to the ICU or the pneumology ward with a suspicion of CAP will be screened

You may qualify if:

  • temperature \> 37.8 °C
  • respiratory rate \> 25/min
  • heat rate \> 100/min
  • cough
  • expectoration
  • chest pain
  • crackles upon lung auscultation
  • and new infiltrate on the chest x-ray

You may not qualify if:

  • ongoing pregnancy
  • sickle cell disease
  • tracheostomy
  • long term oxygen therapy
  • cystic fibrosis or bronchiectasis
  • neutropenia (\< 500 cells/mm3)
  • ongoing solid or hematologic cancer or anticancerous chemotherapy
  • HIV infection
  • liver cirrhosis
  • long term corticosteroid treatment (20mg per day equivalent prednisone for more than 15 days)
  • preexisting treatment with NSAIDs for more than 15 days
  • hospital admission for more than 48hours
  • aspiration pneumonia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre Hospitalier Victor Dupouy

Argenteuil, 95100, France

Location

Louis Mourier Hospital

Colombes, 92700, France

Location

Hôpital Max Fourestier

Nanterre, 92000, France

Location

Tenon Hospital

Paris, 75020, France

Location

Related Publications (2)

  • Voiriot G, Dury S, Parrot A, Mayaud C, Fartoukh M. Nonsteroidal antiinflammatory drugs may affect the presentation and course of community-acquired pneumonia. Chest. 2011 Feb;139(2):387-394. doi: 10.1378/chest.09-3102. Epub 2010 Aug 19.

    PMID: 20724739BACKGROUND

  • Messika J, Sztrymf B, Bertrand F, Billard-Pomares T, Barnaud G, Branger C, Dreyfuss D, Ricard JD. Risks of nonsteroidal antiinflammatory drugs in undiagnosed intensive care unit pneumococcal pneumonia: younger and more severely affected patients. J Crit Care. 2014 Oct;29(5):733-8. doi: 10.1016/j.jcrc.2014.05.021. Epub 2014 Jun 4.

    PMID: 24997726BACKGROUND

MeSH Terms

Conditions

Community-Acquired PneumoniaPneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesLung Diseases

Study Officials

  • Jean-Damien RICARD, MD, PhD

    Asssistance Pulique - Hôpitaux de Paris

    STUDY CHAIR

  • Muriel FARTOUKH, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY CHAIR

  • Jonathan MESSIKA, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Guillaume Voiriot, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • David Hajage, MD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Intensive Care Medicine, assistant head of ICU

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 14, 2015

Study Start

November 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations

FR(4)