An Epidemiological Study to Investigate the Characteristics of RSV Infection in Adult Hematopoietic Cell Transplant Recipients or Hematological Malignancies Patients in Tianjin HI (Hematology Institute)

June 28, 2024 updated by: Institute of Hematology & Blood Diseases Hospital, China
This primary objective of this study is to describe the incidence of RSV infection in adult hematopoietic cell transplant recipients OR hematological malignancies patients in Tianjin HI.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Tianjin, China
        • Recruiting
        • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

adult hematopoietic stem cell transplantation (HCT) recipients OR hematological malignancies (HM) patients have new onset or worsen of respiratory signs/syndromes and presented the study site.

Description

Inclusion Criteria:

  • 1) Aged ≥ 18 years old. 2) Receiving hematopoietic stem cell transplantation; OR being diagnosed with hematological malignancies (including but not limited to leukemia, lymphoma, and multiple myeloma) and receiving chemotherapy.

    3) New onset of respiratory symptoms; OR exacerbation of existing chronic respiratory symptoms (such as previously diagnosed chronic runny nose, seasonal allergies, chronic lung disease, etc.).

    4) Willing to sign an informed consent form, able to understand and willing to follow the study protocol.

Exclusion Criteria:

  • Unwillingness to sign an informed consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of RSV infection in adult hematopoietic stem cell transplantation (HCT) recipients OR hematological malignancies (HM) patients presenting the study site
Time Frame: 1 year
infection incidence
1 year
the Incidence of RSV infection in adult hematopoietic stem cell transplantation (HCT) recipients OR hematological malignancies (HM) patients presenting the hospital
Time Frame: 1 year
infection incidence
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the clinical characteristics of RSV infection
Time Frame: 1 year
symptoms description and scoring of RSV infection
1 year
Clinical outcome and relevant risk factor of RSV infection
Time Frame: 1 year
Clinical outcome and relevant risk factor of RSV infection
1 year
Virological characteristics of RSV infection from D1 through D28, D42 or even longer
Time Frame: 1 year
Clinical outcome and relevant risk factor of RSV infection
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2023

Primary Completion (Estimated)

June 20, 2025

Study Completion (Estimated)

June 20, 2025

Study Registration Dates

First Submitted

December 6, 2023

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2023069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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