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

• 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

Study Overview

• Status: Completed
• Conditions: Bacterial Infection

• Study Type: Observational
• Enrollment (Actual): 335

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Name of NSAIDS	Describe what NSAIDs terms of use contribute to the risk of serious bacterial infections	36 months
type of bacterial infection at risk of worsening when exposed to NSAIDs	Describe what type of bacterial infection is 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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Central Hospital, Nancy, France; University Hospital, Limoges; University Hospital, Grenoble; University Hospital, Tours; Agence Nationale de sécurité du Médicament; LA ROCHE SUR YON HOSPITAL
• Investigators: 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, Central Hospital, Nancy, France; Principal Investigator: Annie-Pierre JONVILLE-BERA, PH, Tours university Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2016
• Primary Completion (Actual): April 10, 2018
• Study Completion (Actual): April 10, 2018

Study Registration Dates

• First Submitted: May 11, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (Estimate): June 9, 2016

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Bacterial Infections; NSAIDs; Severity; Self Medication
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Bacterial Infections
• Other Study ID Numbers: RC15_0364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO