Clinical trial NCT02794831: Exposure to NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and Severity of Community-acquired Bacterial Infections
Official title: Exposure to NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and Severity of Community-acquired Bacterial Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infection
Keywords: NSAIDs
Bacterial Infections
Severity
Self Medication
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Tours
name: University Hospital, Grenoble
name: Central Hospital, Nancy, France
name: University Hospital, Limoges
name: LA ROCHE SUR YON HOSPITAL
name: Agence Nationale de sécurité du Médicament
First posted: 2016-06-09
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.
* 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: exposure to NSAIDs
timeFrame: From the inclusion (J0) to the the end of hospital stay, up to three months
Secondary outcomes:
measure: Name of NSAIDS
timeFrame: 36 months
measure: type of bacterial infection at risk of worsening when exposed to NSAIDs
timeFrame: 36 months
measure: other drugs exposure assessed by questionnaire
timeFrame: 36 months
measure: Duration of NSAID exposure
timeFrame: 36 months
measure: self-medication assessment
timeFrame: 36 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Grenoble
name: Olivier Epaulard, PU-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Limoges
name: Eric DENES, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: LA ROCHE SUR YON HOSPITAL
name: Thomas Guimard, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Tours University Hospital
name: Louis BENARD, PU-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Hospital, Nancy, France
name: Thierry MAY, PU-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Tours University Hospital
name: Annie-Pierre JONVILLE-BERA, PH
role: PRINCIPAL_INVESTIGATOR
References: