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

Bacterial Infection Clinical Trial

— ANAIG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794831
• Other study ID #: RC15_0364
• Status: Completed
• Start date: September 22, 2016
• Est. completion date: April 10, 2018

Study information

• Verified date: September 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: April 10, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections
• Communicable Diseases
• Infection

Locations

Country	Name	City	State
n/a

Sponsors (7)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Name of NSAIDS	Describe what NSAIDs terms of use contribute to the risk of serious bacterial infections	36 months
Secondary	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
Secondary	other drugs exposure assessed by questionnaire		36 months
Secondary	Duration of NSAID exposure		36 months
Secondary	self-medication assessment		36 months