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

Completed

• Conditions: Community-acquired Pneumonia

• Registration Number: NCT02523885
• Lead Sponsor: Hôpital Louis Mourier

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-14
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
binary composite primary endpoint	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 Outcome Measures

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

Trial Locations

Locations (4)

Centre Hospitalier Victor Dupouy; 🇫🇷 Argenteuil, France

Hôpital Max Fourestier; 🇫🇷 Nanterre, France

Louis Mourier Hospital; 🇫🇷 Colombes, France

Tenon Hospital; 🇫🇷 Paris, France