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OpenTrials
Completed

NCT Number: NCT05661604

A Study to Investigate Acute Respiratory Virus Infections in Participants at High Risk for Severe Illness

The purpose of the study is to describe the rate of occurrence of clinical diagnosis of acute respiratory infection (an infection that affects normal breathing) and different types of respiratory pathogens (harmful organisms) of new respiratory infections in a population at high risk for severe illness.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton Health Sciences, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must sign an informed consent form (ICF) indicating understanding the purpose, procedures, and potential risks and benefits of the study, and is willing to participate in the study
  • Participants at high risk for severe respiratory infections due to their immune-suppressive status and who fit in one or more of the following categories: a) Participants with hematologic malignancy (HM) including, but not limited to, acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (ALL), multiple myeloma (MM): i) Newly diagnosed, within 6 months of treatment initiation; including anticipation of cytotoxic and immunomodulatory therapy such as chimeric antigen receptor T (CAR-T) ii) Hematologic relapse within 6 months from anticipating treatment initiation for relapse iii) Participants with a history of HM who have maintained the immunosuppressive status in the opinion of the investigator and after consultation with the sponsor (that is, study responsible physician or scientists) b) Participants with a history of HM who have received hematopoietic cell transplant (HCT) within 1 year for autologous recipients or within 3 years for allogeneic recipients. c) Participants with a non-HM who have received HCT within 1 year for autologous recipients or within 3 years for allogeneic recipients. This can include, but is not limited to, participants who have received HCT due to lymphoproliferative disorders, solid tumors, primary immunodeficiency, bone marrow failure syndromes, hemoglobinopathies, sickle cell disease, or autoimmune disorders. d) Participants who have developed chronic graft vs host disease (GVHD) after HCT and are currently on immunosuppressive therapy
  • Must be able to read, understand, and complete questionnaires
  • Must be willing and able to connect current electronic health records from one or more providers

Exclusion criteria

  • Has a clinical condition other than those specified in inclusion criterion 3 which, in the opinion of the investigator, could prevent, confound, or limit the protocol-specified assessments (for example, asthma and allergies)
  • Is, in the opinion of the investigator, unlikely to adhere to the requirements of the study or is unlikely to complete the full course of observation
  • Cannot communicate reliably with the investigator
  • Has moderate-severe allergies that add complexity to the assessment of acute respiratory infection (ARI) episode
  • Is currently enrolled in an interventional study that could interfere with the assessment of respiratory viral dynamics

Treatment and study plan

No intervention

Other

This is an observational study to assess the incidence and key disease characteristics of symptomatic acute respiratory viral infections in a high-risk population at risk for poor outcomes. Duration of each participant will be up to 12 months.

Primary outcomes

  1. Number of Participants with Clinically Confirmed Acute Respiratory Infection (ARI)

    Time frame: Up to 1 year 3 months

    Number of participants with clinically confirmed ARI will be reported.

  2. Number of Clinically Confirmed ARI Participants With Positive or Negative Infection Status for Each Respiratory Virus Tested

    Time frame: Up to 1 year 3 months

    Number of clinically confirmed ARI participants with positive or negative infection status for each respiratory virus tested will be reported.

Secondary outcomes

  1. Number of Clinically Confirmed ARI Participants who Were Hospitalized

    Time frame: Up to 1 year 3 months

    Number of clinically confirmed ARI participants who were hospitalized will be reported.

  2. Number of Clinically Confirmed ARI Participants who Experienced Complications

    Time frame: Up to 1 year 3 months

    Number of clinically confirmed ARI participants who experienced complications will be reported.

  3. Number of Deaths in Clinically Confirmed ARI Participants

    Time frame: Up to 1 year 3 months

    Number of deaths in clinically confirmed ARI participants will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

Prospective Study to Investigate Acute Respiratory Virus Infections in Patients at High Risk for Severe Illness

Acronym: BREEZE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 22, 2022
Registry last updated
Feb 28, 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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