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CompletedNCT02523885ALPAJUpdated Feb 26, 2016

Use of Non Steroidal Antiinflammatory Drugs in Patients With Community Acquired Pneumonia

An observational study in Community-acquired Pneumonia, sponsored by Hôpital Louis Mourier. Completed at 4 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-02-26.

Sponsored by Hôpital Louis Mourier · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
181
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Recent data suggests that such exposure to NSAIDs is associated with delay in CAP diagnosis and antibiotic prescription that influence CAP presention and outcome. The investigators' working hypothesis is that NSAIDs use may mask initial symptoms and delay antimicrobial therapy, thus predisposing to worse outcomes. All patients presenting at one of the three following locations (emergency department, ICU or pneumology ward) with a suspicion of community-acquired pneumonia will be screened for eligibility. Exposure or not to NSAIDs will be investigated. Clinical, biological and radioloigcal features and outcome of CAP will be compared with respect to NSAIDs exposure.

02

Conditions studied

  • Community-acquired Pneumonia

Keywords

  • Pneumonia, Bacterial [C01.252.620]
  • Bronchopneumonia [C08.381.677.127]
  • Pleuropneumonia [C08.730.610.473]
  • Anti-Inflammatory Agents, Non-Steroidal
03

In context

Community-Acquired Pneumonia

90 studies on the registry are indexed under Community-Acquired Pneumonia; 53 are open to participants now.

This study's enrollment of 181 is below the median of 528 across 29 observational studies indexed under Community-Acquired Pneumonia.

Browse Community-Acquired Pneumonia studies →

Lead sponsor

Hôpital Louis Mourier is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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

Eligibility criteria

Inclusion Criteria: at least two among the following signs

  • 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

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
181 participants (actual)
Patient registry
No
06

What researchers measure

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;

    Time frame: 28 days

Secondary outcomes

  1. pneumonia severity index

    the pneumonia severity index calculated at inclusion will be compared in exposed and non-exposed to NSAID patients

    Time frame: 2 days

  2. CURB score at inclusion

    the CURB score (confusion, blood urea nitrogen, respiratory rate and systolic blood pressure) at inclusion will be compared in exposed and non-exposed to NSAID patients

    Time frame: 2 days

  3. duration of antimicrobial therapy

    Time frame: 28 days

  4. occurence of a nosocomial infection

    occurrence of nosocomial infections (including nosocomial pneumonia, catheter-related blood stream infection, and urinary tract nosocomial infection) will be compared in exposed and non-exposed to NSAID patients

    Time frame: 28 days

  5. 28-day mortality

    Time frame: 28 days

Other outcomes

  1. chest pain

    presence or absence of chest pain at inclusion will compared between exposed and non-exposed to NSAID patients

    Time frame: 2 days

07

Study locations

4 sites
  • Centre Hospitalier Victor Dupouy
    Argenteuil, 95100, France
  • Louis Mourier Hospital
    Colombes, 92700, France
  • Hôpital Max Fourestier
    Nanterre, 92000, France
  • Tenon Hospital
    Paris, 75020, France
08

References and documents

Publications

  • 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. PubMed 20724739 ↗
  • 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. PubMed 24997726 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02523885
Lead sponsor
Hôpital Louis Mourier
Responsible party
Prof Jean-Damien RICARD (Professor of Intensive Care Medicine, assistant head of ICU, Hôpital Louis Mourier) — Principal investigator
First posted
Aug 14, 2015
Start date
Nov 2013
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Feb 26, 2016

Study contacts

Jean-Damien RICARD, MD, PhD
study chair · Asssistance Pulique - Hôpitaux de Paris
Muriel FARTOUKH, MD, PhD
study chair · Assistance Publique - Hôpitaux de Paris
Jonathan MESSIKA, MD
principal investigator · Assistance Publique - Hôpitaux de Paris
Guillaume Voiriot, MD
principal investigator · Assistance Publique - Hôpitaux de Paris
David Hajage, MD
study director · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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