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

Community-acquired Pneumonia Clinical Trial

— ALPAJ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02523885
• Other study ID #: HLM_JDR3
• Status: Completed
• Phase: N/A
• First received: August 13, 2015
• Last updated: February 25, 2016
• Start date: November 2013
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: Hôpital Louis Mourier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Ministère de l'Enseignement supérieur et de la RechercheFrance: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Locations

Country	Name	City	State
France	Centre Hospitalier Victor Dupouy	Argenteuil
France	Louis Mourier Hospital	Colombes
France	Hôpital Max Fourestier	Nanterre
France	Tenon Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Louis Mourier

Country where clinical trial is conducted

France, 

References & Publications (2)

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. Review. — View 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):387-94. doi: 10.1378/chest.09-3102. Epub 2010 Aug 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	chest pain	presence or absence of chest pain at inclusion will compared between exposed and non-exposed to NSAID patients	2 days	No
Primary	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	Yes
Secondary	pneumonia severity index	the pneumonia severity index calculated at inclusion will be compared in exposed and non-exposed to NSAID patients	2 days	No
Secondary	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	2 days	No
Secondary	duration of antimicrobial therapy		28 days	No
Secondary	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	28 days	No
Secondary	28-day mortality		28 days	Yes