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Completed

NCT Number: NCT02794831

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

* 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

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Key information

Conditions

Bacterial Infection Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Name of NSAIDS

    Time frame: 36 months

    Describe what NSAIDs terms of use contribute to the risk of serious bacterial infections

  2. 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.

  3. other drugs exposure assessed by questionnaire

    Time frame: 36 months

  4. Duration of NSAID exposure

    Time frame: 36 months

  5. self-medication assessment

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Agence Nationale de sécurité du Médicament
  • Central Hospital, Nancy, France
  • LA ROCHE SUR YON HOSPITAL
  • University Hospital, Grenoble
  • University Hospital, Limoges
  • University Hospital, Tours

Registry information

Acronym: ANAIG

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 9, 2016
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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