RSV InfectionNCT06490549
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)
An observational study of RSV Infection, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RSV Infection
- What is being tested?
- RSV infection observation cohort
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2023to 20 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Unwillingness to sign an informed consent form.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin
Erlie Jiang, +86-15122538106, jiangerlie@ihcmas.ac.cn
About this study
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.
- Conditions
- RSV Infection
- Being tested
- RSV infection observation cohort
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV infection observation cohortOther
No intervention; Epidemiological Study. Participants will receive standard care based on local clinical practice
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of RSV infection in adult hematopoietic stem cell transplantation (HCT) recipients OR hematological malignancies (HM) patients presenting the study site
infection incidence
Measured: 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
Measured: 1 year
Secondary outcomes (3)
the clinical characteristics of RSV infection
symptoms description and scoring of RSV infection
Measured: 1 year
Clinical outcome and relevant risk factor of RSV infection
Clinical outcome and relevant risk factor of RSV infection
Measured: 1 year
Virological characteristics of RSV infection from D1 through D28, D42 or even longer
Clinical outcome and relevant risk factor of RSV infection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start30 Nov 2023
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490549
- Sponsor's protocol ID
- IIT2023069
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06490549
- Acronym / sponsor ID
- IIT2023069
- Conditions
- RSV Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Unwillingness to sign an informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSV infection observation cohortNo intervention; Epidemiological Study. Participants will receive standard care based on local clinical practice | Other | – |
Primary outcome
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
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
3 secondary outcomes
the clinical characteristics of RSV infection
Time frame: 1 year
Clinical outcome and relevant risk factor of RSV infection
Time frame: 1 year
Virological characteristics of RSV infection from D1 through D28, D42 or even longer
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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RSV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RSV Infection, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erlie Jiang, MD (+86-15122538106, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.