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Recruiting

NCT Number: NCT06735612

Respiratory Syncytial Virus Infection in Exacerbations of Chronic Obstructive Pulmonary Diasease: the RECODE Study

The goal of this observational study is to determine the prevalence of respiratory syncytial virus (RSV) infection and evaluate its association with clinical outcomes in patients with chronic obstructive pulmonary disease (COPD) who experience exacerbations during the RSV season (October-April). The main question it aims to answer is:

* What is the prevalence of RSV infection in patients with COPD during exacerbations in the RSV season? * Does RSV infection lead to worse clinical outcomes, including hospitalization, longer length of stay, acute cardiovascular events, and/or death in patients with COPD exacerbations?

Researchers will compare patients with RSV infection to those without RSV infection to see if RSV infection results in worse clinical outcomes, such as increased hospitalization, longer stays, cardiovascular events, or death.

Participants will:

* Be adults diagnosed with COPD who present to the emergency department or day hospital due to acute exacerbations of their respiratory symptoms. * Receive treatment as per standard clinical care for COPD exacerbations, including long-acting bronchodilators and inhaled corticosteroids, and may complete a course of antibiotics and/or oral corticosteroids if prescribed during hospitalization. * Undergo diagnostic testing for RSV infection as part of the clinical routine to determine the presence or absence of the virus during their exacerbation. * Have clinical outcomes monitored, including hospitalization rate, length of stay, and any acute cardiovascular events, as well as mortality during the exacerbation period. * Provide relevant demographic and clinical data, including medical history, COPD severity, comorbidities, and previous exacerbation events.

Recruiting

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínic de Barcelona

Barcelona, Spain

Location status: Recruiting

Location contact

Àlvar Agustí

CONTACT

93 277 17 01

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female or male
  • ≥50 years of age
  • Seeking urgent medical attention because of ECOPD, as defined by the Rome consensus definition: "in a patient with COPD, an exacerbation is an event characterized by dyspnea and/or cough and sputum that worsen over <14 d, which may be accompanied by tachypnoea and/or tachycardia and is often associated with increased local and systemic inflammation caused by airway infection, pollution, or other insult to the airways"

Exclusion criteria

  • Previous RSV vaccination (other vaccines will be allowed and recorded)
  • Active cancer (or any other disease) that may alter the immune status of the patient
  • Neurologic disorders that incapacitate the participation of the patient
  • No signing of the informed consent

Treatment and study plan

Primary outcomes

  1. To determine the prevalence of RSV infection because of ECOPD during the RSV season (October-April).

    Time frame: 1 year

    To determine the prevalence of RSV infection (defined as the detection of RSV by RT PCR in nasopharyngeal swab, saliva or sputum samples) among COPD patients seeking acute medical attention in the Emergency Room or Day Hospital facilities because of ECOPD during the RSV season (October-April).

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Garcia

CONTACT

[email protected]

+34 645089918

Sponsors and collaborators

Lead sponsor

Fundacio Privada Mon Clinic Barcelona

Other

Registry information

Acronym: RECODE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2024
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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