Exposure to NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and Severity of Community-acquired Bacterial Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 335
- 试验地点
- 1
- 主要终点
- exposure to NSAIDs
研究概览
简要总结
- 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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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
结局指标
主要结局
exposure to NSAIDs
时间窗: 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.
次要结局
- Name of NSAIDS(36 months)
- type of bacterial infection at risk of worsening when exposed to NSAIDs(36 months)
- Duration of NSAID exposure(36 months)
- self-medication assessment(36 months)
- other drugs exposure assessed by questionnaire(36 months)