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


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Trial ID: NCT05661604


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.

Official Title

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

Stanford Investigator(s)

Joe Le Hsu
Joe Le Hsu

Assistant Professor of Medicine (Pulmonary and Critical Care)


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. 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

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

   - 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


other: No Intervention


I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Joe Hsu