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

Overview

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.

Full Title of Study: “Descriptive Analysis of Non Steroidal Antiinflammatory Drugs Use in Patients Diagnosed With Community Acquired Pneumonia”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2015

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.

Clinical Trial Outcome Measures

Primary Measures

  • binary composite primary endpoint
    • Time Frame: 28 days
    • 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;

Secondary Measures

  • pneumonia severity index
    • Time Frame: 2 days
    • the pneumonia severity index calculated at inclusion will be compared in exposed and non-exposed to NSAID patients
  • CURB score at inclusion
    • Time Frame: 2 days
    • 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
  • duration of antimicrobial therapy
    • Time Frame: 28 days
  • occurence of a nosocomial infection
    • Time Frame: 28 days
    • 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
  • 28-day mortality
    • Time Frame: 28 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hôpital Louis Mourier
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof Jean-Damien RICARD, Professor of Intensive Care Medicine, assistant head of ICU – Hôpital Louis Mourier
  • Overall Official(s)
    • 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

References

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.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.