Bacterial InfectionANAIGNCT02794831
Exposure to NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and Severity of Community-acquired Bacterial Infections
An observational study of Bacterial Infection, run by Nantes University Hospital at 1 site in France.
Trial summary
NSAIDs are widely consumed, and some are currently available for self-medication with indications 'Pain and Fever' (Cavalié, National Agency for Drug Safety (ANSM), 2014) There is no recommendation to limit their use in bacterial infections except for chicken pox in children. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infection
- How many people
- 335 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2016to 10 Apr 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Arm type: patient Arm description: adult patient hospitalized in MCO in one of the study centers for severe community bacterial infection, infected with more than one site, and / or abscess collection, and / or a per-cutaneous drainage of the infection, and / or septic surgery. Arm type: control Arm description: Patient hospitalized in the same center (different service or not), during the week or months of the inclusion of cases for infection without abscess or invasive procedure, only one infected site Pairing criteria (case/control analysis): age/Charlson score/type of infection/centre
Who may be able to join
- Patient : adult patient hospitalized in managed care organization (MCO) in one of the study centers for severe community bacterial infection, infected with more than one site, and / or abscess collection, and / or a per-cutaneous drainage of the infection, and / or septic surgery
- Control: Patient hospitalized in the same center (different service or not), during the week or months of the inclusion of cases for infection without abscess or invasive procedure, only one infected site
Who cannot join
- Hematologic or solid neoplasia undergoing chemotherapy, long-term corticosteroid, chronic exposure to NSAIDs, ongoing treatment with methotrexate or monoclonal antibody (anti-tumor necrosis factor (ant-TNF) particular), chronic buffy neutropenia, surgical site infections, catheter infections, disorders of consciousness or cognitive neuro-against-indicating the administration of the drug exposure questionnaire adults under guardianship, minor, no insurance disease, patients already included in a biomedical research with taking medication blind.
Trial locations and contacts
1 site in 1 country.
About this study
- NSAIDs are widely consumed, and some are currently available for self-medication with indications 'Pain and Fever' (Cavalié, National Agency for Drug Safety (ANSM), 2014)
- There is no recommendation to limit their use in bacterial infections except for chicken pox in children.
- To date, no study has highlighted the aggravating role of exposure to NSAIDs on bacterial infections in adults, based on the usual septic severity Levy's score (SSS), and mortality, but it delays adequate antibiotics (Legras, Critical Care, 2009)
- Community-acquired bacterial infections in adults exposed to NSAIDs are serious by their spread (multiple locations), and suppurative character requiring frequent use of invasive procedures such as surgery or drainage. The SSS does not reflect the seriousness of these infections. They are frequently associated with use of ibuprofen (63.4%), and self-medication practices (65.5%).
The main hypothesis is that NSAIDs exposure is associated with a specific severity of community-acquired bacterial infection, marked by dissemination, suppurative complications or even invasive procedures requirement.
Read more
Our objectives are also to:
- Describe what NSAID use terms are associated to the risk of serious bacterial infections: molecule, dosage, duration of exposure, access (prescription or self-medication), associated drugs.
- To determine what type (s) (s) of bacterial infection is worsened by exposure to NSAIDs.
- To determine if other risk factors contribute to severity of bacterial community acquired infection
- To describe hospital costs associated to such severity of bacterial infection
- Conditions
- Bacterial Infection
- Keywords
- NSAIDs, Bacterial Infections, Severity, Self Medication
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patient | Adult patient hospitalized in MCO in one of the study centers for severe community bacterial infection, infected with more than one site, and / or abscess collection, and / or a per-cutaneous drainage of the infection, and / or septic surgery. | |
| control | Patient hospitalized in the same center (different service or not), during the week or months of the inclusion of cases for infection without abscess or invasive procedure, only one infected site |
What is being measured
The primary outcome is the main question the study is designed to answer.
exposure to NSAIDs
The risk studied is the exposure to NSAIDs, the overall medication history will be collected for cases and controls. The standard questionnaire to document medications history, including self-medication, was previously published (Asseray et al., 2013) The window of exposure to drugs is defined as 14 days before hospital admission. Drug exposure will be assessed at the time of inclusion.
Measured: From the inclusion (J0) to the the end of hospital stay, up to three months
Secondary outcomes (5)
Name of NSAIDS
Describe what NSAIDs terms of use contribute to the risk of serious bacterial infections
Measured: 36 months
type of bacterial infection at risk of worsening when exposed to NSAIDs
Describe what type of bacterial infection is at risk of worsening when exposed to NSAIDs.
Measured: 36 months
other drugs exposure assessed by questionnaire
Measured: 36 months
Duration of NSAID exposure
Measured: 36 months
self-medication assessment
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study start22 Sep 2016
- Primary completion10 Apr 2018
- Study completion10 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Tours, University Hospital, Grenoble, Central Hospital, Nancy, France, University Hospital, Limoges, Centre Hospitalier Departemental Vendee, Agence Nationale de sécurité du Médicament
- Responsible party
- Sponsor
- Investigators
- Olivier Epaulard, PU-PH, Principal investigator, University Hospital, GrenobleEric DENES, PH, Principal investigator, University Hospital, LimogesThomas Guimard, PH, Principal investigator, Centre Hospitalier Departemental VendeeLouis BENARD, PU-PH, Principal investigator, Tours University HospitalThierry MAY, PU-PH, Principal investigator, Central Hospital, Nancy, FranceAnnie-Pierre JONVILLE-BERA, PH, Principal investigator, Tours University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794831
- Sponsor's protocol ID
- RC15_0364
- Acronym
- ANAIG
- Status last verified
- Sep 2019
- First submitted
- 11 May 2016
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure to NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and Severity of Community-acquired Bacterial Infections
- ClinicalTrials.gov ID
- NCT02794831
- Acronym / sponsor ID
- ANAIG / RC15_0364
- Conditions
- Bacterial Infection
- Keywords
- NSAIDs, Bacterial Infections, Severity, Self Medication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Tours, University Hospital, Grenoble, Central Hospital, Nancy, France, University Hospital, Limoges, Centre Hospitalier Departemental Vendee, Agence Nationale de sécurité du Médicament
- Study start
- 22 Sep 2016 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 9 Jun 2016 (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.
- NSAIDs are widely consumed, and some are currently available for self-medication with indications 'Pain and Fever' (Cavalié, National Agency for Drug Safety (ANSM), 2014)
- There is no recommendation to limit their use in bacterial infections except for chicken pox in children.
- To date, no study has highlighted the aggravating role of exposure to NSAIDs on bacterial infections in adults, based on the usual septic severity Levy's score (SSS), and mortality, but it delays adequate antibiotics (Legras, Critical Care, 2009)
- Community-acquired bacterial infections in adults exposed to NSAIDs are serious by their spread (multiple locations), and suppurative character requiring frequent use of invasive procedures such as surgery or drainage. The SSS does not reflect the seriousness of these infections. They are frequently associated with use of ibuprofen (63.4%), and self-medication practices (65.5%).
The main hypothesis is that NSAIDs exposure is associated with a specific severity of community-acquired bacterial infection, marked by dissemination, suppurative complications or even invasive procedures requirement.
Our objectives are also to:
- Describe what NSAID use terms are associated to the risk of serious bacterial infections: molecule, dosage, duration of exposure, access (prescription or self-medication), associated drugs.
- To determine what type (s) (s) of bacterial infection is worsened by exposure to NSAIDs.
- To determine if other risk factors contribute to severity of bacterial community acquired infection
- To describe hospital costs associated to such severity of bacterial infection
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient | – | –Adult patient hospitalized in MCO in one of the study centers for severe community bacterial infection, infected with more than one site, and / or abscess collection, and / or a per-cutaneous drainage of the infection, and / or septic surgery. |
| control | – | –Patient hospitalized in the same center (different service or not), during the week or months of the inclusion of cases for infection without abscess or invasive procedure, only one infected site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Arm type: patient Arm description: adult patient hospitalized in MCO in one of the study centers for severe community bacterial infection, infected with more than one site, and / or abscess collection, and / or a per-cutaneous drainage of the infection, and / or septic surgery. Arm type: control Arm description: Patient hospitalized in the same center (different service or not), during the week or months of the inclusion of cases for infection without abscess or invasive procedure, only one infected site Pairing criteria (case/control analysis): age/Charlson score/type of infection/centre
Key inclusion criteria (2 listed)
- Patient : adult patient hospitalized in managed care organization (MCO) in one of the study centers for severe community bacterial infection, infected with more than one site, and / or abscess collection, and / or a per-cutaneous drainage of the infection, and / or septic surgery
- Control: Patient hospitalized in the same center (different service or not), during the week or months of the inclusion of cases for infection without abscess or invasive procedure, only one infected site
Key exclusion criteria (1 listed)
- Hematologic or solid neoplasia undergoing chemotherapy, long-term corticosteroid, chronic exposure to NSAIDs, ongoing treatment with methotrexate or monoclonal antibody (anti-tumor necrosis factor (ant-TNF) particular), chronic buffy neutropenia, surgical site infections, catheter infections, disorders of consciousness or cognitive neuro-against-indicating the administration of the drug exposure questionnaire adults under guardianship, minor, no insurance disease, patients already included in a biomedical research with taking medication blind.
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
exposure to NSAIDs
Time frame: From the inclusion (J0) to the the end of hospital stay, up to three months
The risk studied is the exposure to NSAIDs, the overall medication history will be collected for cases and controls. The standard questionnaire to document medications history, including self-medication, was previously published (Asseray et al., 2013) The window of exposure to drugs is defined as 14 days before hospital admission. Drug exposure will be assessed at the time of inclusion.
5 secondary outcomes
Name of NSAIDS
Time frame: 36 months
type of bacterial infection at risk of worsening when exposed to NSAIDs
Time frame: 36 months
other drugs exposure assessed by questionnaire
Time frame: 36 months
Duration of NSAID exposure
Time frame: 36 months
self-medication assessment
Time frame: 36 months
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 24 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Olivier Epaulard, PU-PH principal investigator
University Hospital, Grenoble
Eric DENES, PH principal investigator
University Hospital, Limoges
Thomas Guimard, PH principal investigator
Centre Hospitalier Departemental Vendee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infection, run by Nantes University Hospital at 1 site 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 2 inclusion and 1 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 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
exposure to NSAIDs (time frame: From the inclusion (J0) to the the end of hospital stay, up to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2026.