NCT06490549

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 8, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

July 8, 2024

Status Verified

December 1, 2023

Enrollment Period

1.6 years

First QC Date

December 6, 2023

Last Update Submit

June 28, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • the incidence of RSV infection in adult hematopoietic stem cell transplantation (HCT) recipients OR hematological malignancies (HM) patients presenting the study site

    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

    infection incidence

    1 year

Secondary Outcomes (3)

  • the clinical characteristics of RSV infection

    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

    1 year

Interventions

No intervention; Epidemiological Study. Participants will receive standard care based on local clinical practice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Unwillingness to sign an informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2023

First Posted

July 8, 2024

Study Start

November 30, 2023

Primary Completion

June 20, 2025

Study Completion

June 20, 2025

Last Updated

July 8, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations