RSV InfectionNCT05767294
Epidemiological and Clinical Characteristics of Hospitalized Patients Under 5 Years Old With RSV Infection in Central China, Wuhan
An observational study of RSV Infection, run by Tongji Hospital at 1 site in China.
Trial summary
The study will be a multicenter, hospital-based retrospective study. We plan to collect the clinical and laboratory data among all hospitalized ARTI cases in three hospitals in Wuhan from June 1, 2020 to May 31, 2023 and then analyze the epidemiological and clinical characteristics of RSV infection, clarify the gene… Read more about this study
- Who is it for?
- Ages 1 day to 5 years
- Conditions the study is for
- RSV Infection
- What is being tested?
- Observation
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2023to 1 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 1 day to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: all hospitalized ARTI cases in three hospitals in Wuhan from June 1, 2020 to May 31, 2023 and then analyze the epidemiological and clinical characteristics of RSV infection, clarify the gene types of epidemics under 5 years old children after the outbreak in Wuhan, China
Who may be able to join
- ①Admission age <5 years old
- ②Clinical diagnosis of acute respiratory tract infections
Who cannot join
- Hospital acquired ARTI
Trial locations and contacts
1 site in 1 country.
China1 site
department of pediatrics, Tongji hospital, Tongji medical college, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
The study will be a multicenter, hospital-based retrospective study. We plan to collect the clinical and laboratory data among all hospitalized ARTI cases in three hospitals in Wuhan from June 1, 2020 to May 31, 2023 and then analyze the epidemiological and clinical characteristics of RSV infection, clarify the gene types of epidemics under 5 years old children after the outbreak in Wuhan, China.
- Conditions
- RSV Infection
- Being tested
- Observation
- 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.
ObservationOther
clinical manifestation (body temperature, fever days before admission, cough, red throat/sore throat, runny nose, shortness of breath, wheezing, vomiting), physical signs (auscultation of lungs, X-ray results), length of stay, therapeutic measures (oxygen therapy, ICU admission, antibiotic therapy, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Neonatal | Not described Receives: Other: Observation | |
| 1-3 months old | Not described Receives: Other: Observation | |
| 3-6 months old | Not described Receives: Other: Observation | |
| 6 months-1 year old | Not described Receives: Other: Observation | |
| 1-2 years old | Not described Receives: Other: Observation | |
| 2-5 years old | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with fever
number of patients with fever
Measured: at admission
number of patients with cough
number of patients with cough
Measured: at admission
number of patients with shortness of breath
number of patients with shortness of breath
Measured: at admission
number of patients with shortness of wheeze
number of patients with shortness of wheeze
Measured: at admission
number of patients with shortness of vomit
number of patients with shortness of vomit
Measured: at admission
number of patients with shortness of rale
number of patients with shortness of rale
Measured: at admission
number of patients with shortness of stridor
number of patients with shortness of stridor
Measured: at admission
age
age
Measured: at admission
gender
female/male
Measured: at admission
number of patients with underlying disease
underlying disease include immune deficiency, CHD, BPD, BO, bronchiectasis and asthma and so on
Measured: at admission
Imaging examination results
X-Ray/CT
Measured: through study completion, an average of 1 year
length of hospital stay length of stay length of stay
length of hospital stay
Measured: through study completion, an average of 1 year
number of patients with treatment of antibiotic
number of patients with treatment of antibiotic
Measured: through study completion, an average of 1 year
number of patients with treatment of immunoglobulin
number of patients with treatment of immunoglobulin
Measured: through study completion, an average of 1 year
number of patients with treatment of glucocorticoids
number of patients with treatment of glucocorticoids
Measured: through study completion, an average of 1 year
number of patients with treatment of oxygen inhalation
number of patients with treatment of oxygen inhalation
Measured: through study completion, an average of 1 year
number of patients with treatment of ventilation
number of patients with treatment of ventilation
Measured: through study completion, an average of 1 year
direct medical cost
direct medical cost
Measured: through study completion, an average of 1 year
proportion of different virus genotype
virus genotype include A, B and C
Measured: through study completion, an average of 1 year
F protein gene sequence
F protein gene sequence
Measured: through study completion, an average of 1 year
number of patients infected with bacteria
number of patients infected with bacteria
Measured: through study completion, an average of 1 year
number of patients infected with virus
number of patients infected with virus
Measured: through study completion, an average of 1 year
number of patients infected with fungus
number of patients infected with fungus
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start5 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion1 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 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sainan Shu, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767294
- Sponsor's protocol ID
- MISP-100898
- Status last verified
- Apr 2024
- First submitted
- 16 Feb 2023
- Last updated
- 22 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological and Clinical Characteristics of Hospitalized Patients Under 5 Years Old With RSV Infection in Central China, Wuhan
- ClinicalTrials.gov ID
- NCT05767294
- Acronym / sponsor ID
- MISP-100898
- Conditions
- RSV Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 14 Mar 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.
The study will be a multicenter, hospital-based retrospective study. We plan to collect the clinical and laboratory data among all hospitalized ARTI cases in three hospitals in Wuhan from June 1, 2020 to May 31, 2023 and then analyze the epidemiological and clinical characteristics of RSV infection, clarify the gene types of epidemics under 5 years old children after the outbreak in Wuhan, China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Neonatal | – | Other: Observation |
| 1-3 months old | – | Other: Observation |
| 3-6 months old | – | Other: Observation |
| 6 months-1 year old | – | Other: Observation |
| 1-2 years old | – | Other: Observation |
| 2-5 years old | – | Other: Observation |
Who may qualify
- Ages
- 1 day to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- all hospitalized ARTI cases in three hospitals in Wuhan from June 1, 2020 to May 31, 2023 and then analyze the epidemiological and clinical characteristics of RSV infection, clarify the gene types of epidemics under 5 years old children after the outbreak in Wuhan, China
Key inclusion criteria (2 listed)
- ①Admission age <5 years old
- ②Clinical diagnosis of acute respiratory tract infections
Key exclusion criteria (1 listed)
- Hospital acquired ARTI
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 |
|---|---|---|
| Observationclinical manifestation (body temperature, fever days before admission, cough, red throat/sore throat, runny nose, shortness of breath, wheezing, vomiting), physical signs (auscultation of lungs, X-ray results), length of stay, therapeutic measures (oxygen therapy, ICU admission, antibiotic therapy, etc.) | Other | 1-2 years old, 1-3 months old, 2-5 years old, 3-6 months old, 6 months-1 year old, Neonatal |
Primary outcome
number of patients with fever
Time frame: at admission
number of patients with fever
number of patients with cough
Time frame: at admission
number of patients with cough
number of patients with shortness of breath
Time frame: at admission
number of patients with shortness of breath
number of patients with shortness of wheeze
Time frame: at admission
number of patients with shortness of wheeze
number of patients with shortness of vomit
Time frame: at admission
number of patients with shortness of vomit
number of patients with shortness of rale
Time frame: at admission
number of patients with shortness of rale
number of patients with shortness of stridor
Time frame: at admission
number of patients with shortness of stridor
age
Time frame: at admission
age
gender
Time frame: at admission
female/male
number of patients with underlying disease
Time frame: at admission
underlying disease include immune deficiency, CHD, BPD, BO, bronchiectasis and asthma and so on
Imaging examination results
Time frame: through study completion, an average of 1 year
X-Ray/CT
length of hospital stay length of stay length of stay
Time frame: through study completion, an average of 1 year
length of hospital stay
number of patients with treatment of antibiotic
Time frame: through study completion, an average of 1 year
number of patients with treatment of antibiotic
number of patients with treatment of immunoglobulin
Time frame: through study completion, an average of 1 year
number of patients with treatment of immunoglobulin
number of patients with treatment of glucocorticoids
Time frame: through study completion, an average of 1 year
number of patients with treatment of glucocorticoids
number of patients with treatment of oxygen inhalation
Time frame: through study completion, an average of 1 year
number of patients with treatment of oxygen inhalation
number of patients with treatment of ventilation
Time frame: through study completion, an average of 1 year
number of patients with treatment of ventilation
direct medical cost
Time frame: through study completion, an average of 1 year
direct medical cost
proportion of different virus genotype
Time frame: through study completion, an average of 1 year
virus genotype include A, B and C
F protein gene sequence
Time frame: through study completion, an average of 1 year
F protein gene sequence
number of patients infected with bacteria
Time frame: through study completion, an average of 1 year
number of patients infected with bacteria
number of patients infected with virus
Time frame: through study completion, an average of 1 year
number of patients infected with virus
number of patients infected with fungus
Time frame: through study completion, an average of 1 year
number of patients infected with fungus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tongji Hospital 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 2 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 22 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with fever (time frame: at admission). The study lists 23 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 22 Apr 2024.