Community-acquired PneumoniaALPAJNCT02523885
Use of Non Steroidal Antiinflammatory Drugs in Patients With Community Acquired Pneumonia
An observational study of Community-acquired Pneumonia, run by Hôpital Louis Mourier at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Community-acquired Pneumonia
- How many people
- 181 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2013to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- ongoing pregnancy
- sickle cell disease
- tracheostomy
- long term oxygen therapy
- cystic fibrosis or bronchiectasis
- neutropenia (< 500 cells/mm3)
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Hospitalier Victor Dupouy
Argenteuil, 95100
Louis Mourier Hospital
Colombes, 92700
Hôpital Max Fourestier
Nanterre, 92000
Tenon Hospital
Paris, 75020
About this study
Official title: 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.
Read the 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.
- Conditions
- Community-acquired Pneumonia
- Keywords
- Pneumonia, Bacterial [C01.252.620], Bronchopneumonia [C08.381.677.127], Pleuropneumonia [C08.730.610.473], Anti-Inflammatory Agents, Non-Steroidal
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 28 days
Secondary outcomes (5)
pneumonia severity index
the pneumonia severity index calculated at inclusion will be compared in exposed and non-exposed to NSAID patients
Measured: 2 days
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
Measured: 2 days
duration of antimicrobial therapy
Measured: 28 days
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
Measured: 28 days
28-day mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startNov 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Louis Mourier
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Jean-Damien RICARD, Hôpital Louis Mourier
- Investigators
- Jean-Damien RICARD, MD, PhD, Study chair, Asssistance Pulique - Hôpitaux de ParisMuriel FARTOUKH, MD, PhD, Study chair, Assistance Publique - Hôpitaux de ParisJonathan MESSIKA, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisGuillaume Voiriot, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisDavid Hajage, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523885
- Sponsor's protocol ID
- HLM_JDR3
- Acronym
- ALPAJ
- Status last verified
- Feb 2016
- First submitted
- 13 Aug 2015
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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):387-394. doi: 10.1378/chest.09-3102. Epub 2010 Aug 19.
PubMed 20724739Messika 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.
PubMed 24997726
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Analysis of Non Steroidal Antiinflammatory Drugs Use in Patients Diagnosed With Community Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT02523885
- Acronym / sponsor ID
- ALPAJ / HLM_JDR3
- Conditions
- Community-acquired Pneumonia
- Keywords
- Pneumonia, Bacterial [C01.252.620], Bronchopneumonia [C08.381.677.127], Pleuropneumonia [C08.730.610.473], Anti-Inflammatory Agents, Non-Steroidal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Hôpital Louis MourierUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- temperature > 37.8 °C
- respiratory rate > 25/min
- heat rate > 100/min
- cough
- expectoration
Key exclusion criteria (13 listed)
- ongoing pregnancy
- sickle cell disease
- tracheostomy
- long term oxygen therapy
- cystic fibrosis or bronchiectasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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;
5 secondary outcomes
pneumonia severity index
Time frame: 2 days
CURB score at inclusion
Time frame: 2 days
duration of antimicrobial therapy
Time frame: 28 days
occurence of a nosocomial infection
Time frame: 28 days
28-day mortality
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Background: PubMed 20724739Voiriot 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):387-394. doi: 10.1378/chest.09-3102. Epub 2010 Aug 19.
- Background: PubMed 24997726Messika 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Damien RICARD, MD, PhD study chair
Asssistance Pulique - Hôpitaux de Paris
Muriel FARTOUKH, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
Jonathan MESSIKA, MD principal investigator
Assistance Publique - Hôpitaux de Paris
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-acquired Pneumonia, run by Hôpital Louis Mourier at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
binary composite primary endpoint (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02523885, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.