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Completed

NCT Number: NCT02523885

Use of Non Steroidal Antiinflammatory Drugs in Patients 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Victor Dupouy, Argenteuil, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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. 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

  3. duration of antimicrobial therapy

    Time frame: 28 days

  4. 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

  5. 28-day mortality

    Time frame: 28 days

Other outcomes

  1. chest pain

    Time frame: 2 days

    presence or absence of chest pain at inclusion will compared between exposed and non-exposed to NSAID patients

Sponsors and collaborators

Lead sponsor

Hôpital Louis Mourier

Other

Registry information

Official study title

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

Acronym: ALPAJ

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 14, 2015
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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