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临床试验/NCT04662047
NCT04662047招募中不适用

The Impact of Air Pollution on the Consumption of Antimicrobials in the General Population (the ONAIR Project)

Hospital Universitari de Bellvitge1 个研究点 分布在 1 个国家目标入组 3,249,128 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,249,128
试验地点
1
主要终点
Concentration of the PM 2.5

研究概览

简要总结

Objectives: To test the hypothesis that certain levels of air pollution may lead to increases in 1) antimicrobial consumption in the general population and 2) the presence of antibiotic resistance genes.

Methods: The project will consist of two sub-studies:

  1. A time series analysis of the association between daily antimicrobial consumption and air pollution in the 11 largest cities in Catalonia (2006-2022). Outcome variable: daily consumption of antimicrobials. Independent variables: air pollution and confounding variables. The analysis will use generalized additive models: through a random effects meta-analysis, the concentration-response estimates for each city will be added together to calculate the overall estimates.
  2. Descriptive observational study of the relationship between the concentration of resistance genes and antimicrobial consumption in the Barcelona area (2021-2023).

Outcome variable: concentration of antibiotic resistance genes. Independent variables: defined daily dose of antimicrobials per 1000 inhabitants-day. Descriptive analysis of the concentration and diversity of antibiotic resistance genes according to air quality monitoring station (urban vs. hospital environment), month, and correlation with antimicrobial consumption.

详细描述

The ONAIR project will consist of the two sub-studies described below:

SUBSTUDY 1

1.1 Design: A two-part time series analysis of the association between the concentration of the main air pollutants (PM2.5, PM10, NO2, O3) between 2006 and 2022 and the daily antimicrobial consumption by the general population.

1.2 Scope of the study and authorized sources of information: The study will be carried out in the 11 cities in Catalonia with more than 100,000 inhabitants, distributed in the four provinces of the region. These cities are home to 3,283,501 people. Daily data on air pollution will be obtained from the Atmospheric Pollution Monitoring and Forecasting Network (XVPCA). Daily consumption of antimicrobials will be estimated from the official prescription data recorded by the Council of the College of Pharmacists of Catalonia (CCFC) authorized by the Department of Health in Catalonia. The secondary clinical variables under study will be obtained through the Agency for Quality and Health Assessment of Catalonia.

1.3 Study subjects: Adults and children living in the 11 cities under study.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Concentration of the PM 2.5

时间窗: 2006 - 2023

Concentration of the particulate matter (2.5µ)

Concentration of the SO2

时间窗: 2006 - 2023

Concentration of sulfur dioxide

DDD of antimicrobials per 1000 inhabitants-day

时间窗: 2006 - 2023

defined daily dose of antimicrobials per 1000 inhabitants-day in general population

Concentration of antibiotic resistance genes.

时间窗: 2021 - 2023

Concentration of antibiotic resistance genes suspended in the air of Barcelona city

Concentration of the NO2

时间窗: 2006 - 2023

Concentration of nitrogen dioxide

Concentration of the PM10

时间窗: 2006 - 2023

Concentrations of particulate matter (10µ)

次要结局

  • Mortality due to natural(2006 - 2023)
  • Number of hospital admissions due to respiratory causes(2006 - 2023)
  • Number of primary care consultations due to respiratory causes(2006 - 2023)

研究者

发起方
Hospital Universitari de Bellvitge
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jordi Carratala

Head of Infectious Diseases

Hospital Universitari de Bellvitge

研究点 (1)

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