Clinical trial NCT02523885: Use of Non Steroidal Antiinflammatory Drugs in Patients With Community Acquired Pneumonia
Official title: Descriptive Analysis of Non Steroidal Antiinflammatory Drugs Use in Patients Diagnosed With Community Acquired Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Hôpital Louis Mourier
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

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

Primary outcomes:
measure: binary composite primary endpoint
timeFrame: 28 days
Secondary outcomes:
measure: pneumonia severity index
timeFrame: 2 days
measure: CURB score at inclusion
timeFrame: 2 days
measure: duration of antimicrobial therapy
timeFrame: 28 days
measure: occurence of a nosocomial infection
timeFrame: 28 days
measure: 28-day mortality
timeFrame: 28 days
Other outcomes:
measure: chest pain
timeFrame: 2 days
Locations:
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Colombes
country: France
facility: Louis Mourier Hospital
city: Nanterre
country: France
facility: Hôpital Max Fourestier
city: Paris
country: France
facility: Tenon Hospital
Study officials:
affiliation: Asssistance Pulique - Hôpitaux de Paris
name: Jean-Damien RICARD, MD, PhD
role: STUDY_CHAIR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Muriel FARTOUKH, MD, PhD
role: STUDY_CHAIR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jonathan MESSIKA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Guillaume Voiriot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: David Hajage, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.