Severe Fever With Thrombocytopenia SyndromeNCT06011902
A 6-month Follow-up Study of Patients With Severe Fever With Thrombocytopenia Syndrome
An observational study of Severe Fever With Thrombocytopenia Syndrome, run by Tongji Hospital at 8 sites in China.
Trial summary
This is a multi-center, retrospective clinical study to analyze the clinical features, laboratory indicators, imaging changes, treatment options and long-term prognosis in patients with sever fever with thrombocytopenia syndrome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Fever With Thrombocytopenia Syndrome
- How many people
- 1,500 participants
- Where
- 8 sitesChina
- Study dates
- 25 Oct 2021to 31 Mar 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized patients diagnosed with severe fever with thrombocytopenia syndrome from 8 centers in Hubei Province, China.
Who may be able to join
- Age and gender are not limited;
- Hospitalized patients diagnosed with severe fever with thrombocytopenia syndrome have at least one of the following laboratory test results: serum severe fever with thrombocytopenia syndrome bunyavirus (SFTSV)-specific IgM antibody positive or IgG antibody level increased more than 4 times; or positive for SFTSV RNA; or positive for SFTSV nucleic acid detected by real-time fluorescent quantitative RT-PCR; or SFTSV isolated from case specimens.
Who cannot join
- Patients who were found to be positive for other tick-borne pathogens by PCR analysis of blood samples in the acute phase;
- It is difficult to conduct outpatient follow-up due to mental disorders, dementia, combined diseases such as osteoarthropathy, stroke, pulmonary embolism, etc. that lead to inability to move freely;
- No outpatient follow-up visit after discharge, and repeated confirmation by phone call still unable to get in touch;
- Due to living in other places, nursing homes, welfare homes, unable to participate in outpatient follow-up after making an appointment by phone;
- Currently participating in clinical trials of other drugs or medical devices;
- The researchers think it is not suitable for inclusion.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
NO.1 Peoples Hospital of Guangshui
Guangshui, Hubei
qian Liu, liuqian060685@163.com
- Recruiting
Huanggang Central Hospital
Huanggang, Hubei
yaping Li, 1061319323@qq.com
- Recruiting
People's Hospital Of Luotian County
Huanggang, Hubei
wei Wang, 196436547@qq.com
- Recruiting
People's Hospital of Macheng city Affiliated Hospital of Hubei Univerciy of science and technology
Macheng, Hubei
yi Zhou, 2513478349@qq.com
- Recruiting
Suizhou Central Hospital
Suizhou, Hubei
tiantong Zhou, 2063151328@qq.com
- Recruiting
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Qin Ning, professor, qning@vip.sina.com
- Recruiting
Xianning Central Hospital
Xianning, Hubei
jun Zhu, 1356266581@qq.com
- Recruiting
Yichang Third Peoples Hospital
Yichang, Hubei
quan Ming, 737695825@qq.com
About this study
This is a multi-center, retrospective clinical study to analyze the clinical features, laboratory indicators, imaging changes, treatment options and long-term prognosis in patients with sever fever with thrombocytopenia syndrome. All hospitalized patients with sever fever with thrombocytopenia diagnosed between 2016 and 2022 were included from the electronic medical record system of 8 centers, and demographics, hospitalization information, clinical information, laboratory or imaging examinations, treatment options, and outcomes were collected.
- Medical subject headings
- Severe Fever with Thrombocytopenia Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
The presense of clinical symptoms of patients at 3 months and 6 months after discharge
The number and severity of clinical symptoms of patients.
Measured: 3 months,6 months
Secondary outcomes (1)
Number of participants with different outcome of disease
Number of participants who experience these events:
- discharge with improvement
- death
- automatic discharge
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start25 Oct 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Fever With Thrombocytopenia SyndromeStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Ning, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011902
- Sponsor's protocol ID
- RESORT
- Status last verified
- Aug 2023
- First submitted
- 8 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-month Follow-up Study of Patients With Severe Fever With Thrombocytopenia Syndrome
- ClinicalTrials.gov ID
- NCT06011902
- Acronym / sponsor ID
- RESORT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 25 Aug 2023 (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 is a multi-center, retrospective clinical study to analyze the clinical features, laboratory indicators, imaging changes, treatment options and long-term prognosis in patients with sever fever with thrombocytopenia syndrome. All hospitalized patients with sever fever with thrombocytopenia diagnosed between 2016 and 2022 were included from the electronic medical record system of 8 centers, and demographics, hospitalization information, clinical information, laboratory or imaging examinations, treatment options, and outcomes were collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized patients diagnosed with severe fever with thrombocytopenia syndrome from 8 centers in Hubei Province, China.
Key inclusion criteria (2 listed)
- Age and gender are not limited;
- Hospitalized patients diagnosed with severe fever with thrombocytopenia syndrome have at least one of the following laboratory test results: serum severe fever with thrombocytopenia syndrome bunyavirus (SFTSV)-specific IgM antibody positive or IgG antibody level increased more than 4 times; or positive for SFTSV RNA; or positive for SFTSV nucleic acid detected by real-time fluorescent quantitative RT-PCR; or SFTSV isolated from case specimens.
Key exclusion criteria (6 listed)
- Patients who were found to be positive for other tick-borne pathogens by PCR analysis of blood samples in the acute phase;
- It is difficult to conduct outpatient follow-up due to mental disorders, dementia, combined diseases such as osteoarthropathy, stroke, pulmonary embolism, etc. that lead to inability to move freely;
- No outpatient follow-up visit after discharge, and repeated confirmation by phone call still unable to get in touch;
- Due to living in other places, nursing homes, welfare homes, unable to participate in outpatient follow-up after making an appointment by phone;
- Currently participating in clinical trials of other drugs or medical devices;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The presense of clinical symptoms of patients at 3 months and 6 months after discharge
Time frame: 3 months,6 months
The number and severity of clinical symptoms of patients.
1 secondary outcome
Number of participants with different outcome of disease
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Fever With Thrombocytopenia Syndrome, run by Tongji Hospital at 8 sites 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 2 inclusion and 6 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 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 Qin Ning, Professor (+8613971521450, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presense of clinical symptoms of patients at 3 months and 6 months after discharge (time frame: 3 months,6 months). 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 25 Aug 2023.