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

February 25, 2016 updated by: Prof Jean-Damien RICARD, Hôpital Louis Mourier

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

181

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Argenteuil, France, 95100
        • Centre Hospitalier Victor Dupouy
      • Colombes, France, 92700
        • Louis Mourier Hospital
      • Nanterre, France, 92000
        • Hôpital Max Fourestier
      • Paris, France, 75020
        • Tenon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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;
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day mortality
Time Frame: 28 days
28 days
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
2 days
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
2 days
duration of antimicrobial therapy
Time Frame: 28 days
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 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
chest pain
Time Frame: 2 days
presence or absence of chest pain at inclusion will compared between exposed and non-exposed to NSAID patients
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Louis Mourier

Investigators

  • Study Chair: Jean-Damien RICARD, MD, PhD, Asssistance Pulique - Hôpitaux de Paris
  • Study Chair: Muriel FARTOUKH, MD, PhD, Assistance Publique - Hôpitaux de Paris
  • Principal Investigator: Jonathan MESSIKA, MD, Assistance Publique - Hôpitaux de Paris
  • Principal Investigator: Guillaume Voiriot, MD, Assistance Publique - Hôpitaux de Paris
  • Study Director: David Hajage, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLM_JDR3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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