Exposure to NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and Severity of Community-acquired Bacterial Infections

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

Conditions

• Bacterial Infection

Sponsors & Collaborators

• University Hospital, Tours

  collaborator OTHER

• University Hospital, Grenoble

  collaborator OTHER

• Central Hospital, Nancy, France

  collaborator OTHER

• University Hospital, Limoges

  collaborator OTHER

• LA ROCHE SUR YON HOSPITAL

  collaborator UNKNOWN

• Agence Nationale de sécurité du Médicament

  collaborator OTHER

• Nantes University Hospital

  lead OTHER

Principal Investigators

• Olivier Epaulard, PU-PH · University Hospital, Grenoble

• Eric DENES, PH · University Hospital, Limoges

• Thomas Guimard, PH · LA ROCHE SUR YON HOSPITAL

• Louis BENARD, PU-PH · Tours University Hospital

• Thierry MAY, PU-PH · Central Hospital, Nancy, France

• Annie-Pierre JONVILLE-BERA, PH · Tours University Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-22

Primary Completion

2018-04-10

Completion

2018-04-10