Actively Recruiting

Age: 18Years - 99Years
All Genders
ID06286007

Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control

Led by Hospital Clinico Universitario de Santiago · Updated on 2024-03-01

784

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

Sponsors

H

Hospital Clinico Universitario de Santiago

Lead Sponsor

T

Translational Research In Airway Diseases Group (TRIAD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the yearly frequency of Bordetella pertussis and respiratory syncytial virus (RSV) infections in adults aged 18 and older who have asthma. The study is a multicenter prospective cohort conducted across 35 centers in Spain. It aims to identify these infections using PCR tests performed at specific times after symptoms begin in patients with acute respiratory infections (ARI). Participants will report any asthma flare-ups or acute respiratory infection symptoms over a two-year follow-up. When symptoms occur, a nasopharyngeal swab PCR test will be done for pertussis if symptoms started within the past three weeks, and for RSV if symptoms began within the past 72 hours. This helps to detect and track the infections during the study period. During the study, participants will regularly report symptoms, and researchers will collect samples based on symptom timing. They will measure the incidence of pertussis and RSV infections over two years and assess asthma severity and control linked to these infections. The study also includes seroprevalence evaluations for both pathogens. Participants’ data and health status will be monitored throughout the follow-up period.

CONDITIONS

Brief Title

Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient aged 18 years and over
  • Diagnosed with asthma at least one year before enrollment
  • Able and willing to comply with study requirements during follow-up
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • History of pertussis infection within the last 12 months
  • Acute respiratory infection within 2 weeks before enrollment
  • Presence of respiratory diseases other than asthma
  • Alcohol or drug abuse at enrollment
  • Active cancer or under cancer treatment or follow-up
  • Pregnant women
  • Use of immunosuppressive or immunomodulating agents unrelated to asthma
  • Vaccinated for RSV prior to or during the study (data collected before vaccination included)
  • Vaccinated for Bordetella pertussis within the past 12 months
  • Plans to move away during the study period

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - As needed during 2 years

Participants report symptoms of acute respiratory infection or asthma exacerbation and may undergo nasopharyngeal swab specimens for PCR testing for Bordetella pertussis and RSV based on symptom onset timing.

Visits occur depending on symptom onset within the 2-year follow-up

Long-term Monitoring

Duration - 2 years

Participants are followed for 2 years to monitor the incidence and impact of Bordetella pertussis and RSV infections on asthma severity and control.

Participants report symptoms as they occur; no scheduled visits

Trial Site Locations

Total: 1 location

1

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain, 15706

Actively Recruiting

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Research Team

F

Francisco-Javier GONZALEZ BARCALA, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

A systematic review of adult tetanus-diphtheria-acellular (Tdap) coverage among healthcare workers.

Bruno A Randi, Odeli Nicole Encinas Sejas, Karina T Miyaji...

https://pubmed.ncbi.nlm.nih.gov/30630694