Exposure to NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and Severity of Community-acquired Bacterial Infections (ANAIG)
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|ClinicalTrials.gov Identifier: NCT02794831|
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : September 20, 2019
- 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
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||335 participants|
|Official Title:||Exposure to NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and Severity of Community-acquired Bacterial Infections|
|Actual Study Start Date :||September 22, 2016|
|Actual Primary Completion Date :||April 10, 2018|
|Actual Study Completion Date :||April 10, 2018|
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.
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
- 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.
- type of bacterial infection at risk of worsening when exposed to NSAIDs [ Time Frame: 36 months ]Describe what type of bacterial infection is at risk of worsening when exposed to NSAIDs.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794831
|Principal Investigator:||Olivier Epaulard, PU-PH||University Hospital, Grenoble|
|Principal Investigator:||Eric DENES, PH||University Hospital, Limoges|
|Principal Investigator:||Thomas Guimard, PH||LA ROCHE SUR YON HOSPITAL|
|Principal Investigator:||Louis BENARD, PU-PH||Tours University Hospital|
|Principal Investigator:||Thierry MAY, PU-PH||Nancy University Hospital|
|Principal Investigator:||Annie-Pierre JONVILLE-BERA, PH||Tours University Hospital|