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

NCT02794831 | Completed DMC

• 1 other identifier: RC15_0364
• Study Type: observational
• Target: 335
• Locations: 0 countries
• Sites: N/A

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

Conditions

Bacterial Infection

Keywords

NSAIDs; Bacterial Infections; Severity; Self Medication

Outcome Measures

Primary Outcomes (1)

• exposure to NSAIDs

  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.

  From the inclusion (J0) to the the end of hospital stay, up to three months

Secondary Outcomes (5)

• Name of NSAIDS

  36 months

• type of bacterial infection at risk of worsening when exposed to NSAIDs

  36 months

• other drugs exposure assessed by questionnaire

  36 months

• Duration of NSAID exposure

  36 months

• self-medication assessment

  36 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• 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

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

• Annie-Pierre JONVILLE-BERA, PH

  Tours University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: June 9, 2016
• Study Start: September 22, 2016
• Primary Completion: April 10, 2018
• Study Completion: April 10, 2018
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share