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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02523885
Other study ID # HLM_JDR3
Secondary ID
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


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
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