NCT04662047

Brief Summary

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. 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. 2.Descriptive observational study of the relationship between the concentration of resistance genes and antimicrobial consumption in the Barcelona area (2021-2023).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,249,128

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

3 years

First QC Date

December 4, 2020

Last Update Submit

January 23, 2023

Conditions

Community-acquired PneumoniaAir PollutionDrug Resistance, Microbial

Keywords

air pollutionantimicrobial resistanceantimicrobial consumptioncommunity-acquired Pneumonia

Outcome Measures

Primary Outcomes (6)

  • DDD of antimicrobials per 1000 inhabitants-day

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

    2006 - 2023

  • Concentration of antibiotic resistance genes.

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

    2021 - 2023

  • Concentration of the PM10

    Concentrations of particulate matter (10µ)

    2006 - 2023

  • Concentration of the PM 2.5

    Concentration of the particulate matter (2.5µ)

    2006 - 2023

  • Concentration of the NO2

    Concentration of nitrogen dioxide

    2006 - 2023

  • Concentration of the SO2

    Concentration of sulfur dioxide

    2006 - 2023

Secondary Outcomes (3)

  • 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

Study Arms (1)

Adults and children living in the 11 principal cities of Cataluña, Spain.

Adults and children living in the 11 principal cities of Cataluña, Spain: Barcelona, Hospitalet de Llobregat, Tarrasa, Badalona, Sabadell, Lérida, Tarragona, Mataró, Santa Coloma de Gramanet, Reus, Girona.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults and children living in the 11 principal cities of Cataluña, Spain.

Population based study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Hospital de Bellvitge

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Marc Marí-Dell'Olmo, PhD

    Public Health Barcelona Agency

    STUDY CHAIR

  • Ariadna Padullés, PhD

    Bellvitge University Hospital

    STUDY CHAIR

  • Adriana Vergara, PhD

    Clinic University Hospital

    STUDY CHAIR

Central Study Contacts

Jordi Carratalà, PhD

CONTACT

+34 932 60 75 00jcarratala@idibell.cat

Gabriela Abelenda Alonso, MD

CONTACT

+34 932 60 75 00gabi.abelenda.alonso@gmail.com

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Infectious Diseases

Study Record Dates

First Submitted

December 4, 2020

First Posted

December 10, 2020

Study Start

January 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

The project will be communicated in the main usual scientific forums (congresses and scientific journals), but also, report the results of the investigation to conventional media: notes in the written press, televisions and in particular online media. In addition, a corporate Twitter account of the project will be created (https://twitter.com/ onair\_project) to have a direct channel of communication with the population and with other professionals who can contribute ideas in real time. On the other hand, through the usual dissemination channel of the Biomedical Research Institute of Bellvitge (IDIBELL, OUTREACH program: http://www.idibell.cat/en/event-type/outreach) will propose the making of videos for the official YouTube channel. In addition, the team will present its candidacy for a mini-conference (10 minutes) TEDx about the project once the results are available.

Locations

ES(1)