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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
Sponsor:
Collaborators:
University Hospital, Tours
University Hospital, Grenoble
Central Hospital, Nancy, France
University Hospital, Limoges
LA ROCHE SUR YON HOSPITAL
Agence Nationale de sécurité du Médicament
Information provided by (Responsible Party):
Nantes University Hospital

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

Condition or disease
Bacterial Infection

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Study Type : Observational
Actual Enrollment : 335 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Nantes University Hospital
University Hospital, Tours
University Hospital, Grenoble
Central Hospital, Nancy, France
University Hospital, Limoges
LA ROCHE SUR YON HOSPITAL
Agence Nationale de sécurité du Médicament
Investigators
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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
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02794831    
Other Study ID Numbers: RC15_0364
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nantes University Hospital:
NSAIDs
Bacterial Infections
Severity
Self Medication
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections