Epidemiological and Clinical Characteristics of Hospitalized Patients Under 5 Years Old With RSV Infection in Central China, Wuhan

RSV Infection Clinical Trial

Official title:

Epidemiological and Clinical Characteristics of Hospitalized Patients Under 5 Years Old With RSV Infection in Central China, Wuhan

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05767294
• Other study ID #: MISP-100898
• Status: Enrolling by invitation
• Start date: December 5, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 types of epidemics under 5 years old children after the outbreak in Wuhan, China.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 5 Years

Eligibility

Inclusion Criteria:

?Admission age <5 years old ?Clinical diagnosis of acute respiratory tract infections Exclusion Criteria: Hospital acquired ARTI

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Respiratory Syncytial Virus Infections
• RSV Infection

Intervention

Other:
• Observation
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.)

Locations

Country	Name	City	State
China	department of pediatrics, Tongji hospital, Tongji medical college, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with fever	number of patients with fever	at admission
Primary	number of patients with cough	number of patients with cough	at admission
Primary	number of patients with shortness of breath	number of patients with shortness of breath	at admission
Primary	number of patients with shortness of wheeze	number of patients with shortness of wheeze	at admission
Primary	number of patients with shortness of vomit	number of patients with shortness of vomit	at admission
Primary	number of patients with shortness of rale	number of patients with shortness of rale	at admission
Primary	number of patients with shortness of stridor	number of patients with shortness of stridor	at admission
Primary	age	age	at admission
Primary	gender	female/male	at admission
Primary	number of patients with underlying disease	underlying disease include immune deficiency, CHD, BPD, BO, bronchiectasis and asthma and so on	at admission
Primary	Imaging examination results	X-Ray/CT	through study completion, an average of 1 year
Primary	length of hospital stay length of stay length of stay	length of hospital stay	through study completion, an average of 1 year
Primary	number of patients with treatment of antibiotic	number of patients with treatment of antibiotic	through study completion, an average of 1 year
Primary	number of patients with treatment of immunoglobulin	number of patients with treatment of immunoglobulin	through study completion, an average of 1 year
Primary	number of patients with treatment of glucocorticoids	number of patients with treatment of glucocorticoids	through study completion, an average of 1 year
Primary	number of patients with treatment of oxygen inhalation	number of patients with treatment of oxygen inhalation	through study completion, an average of 1 year
Primary	number of patients with treatment of ventilation	number of patients with treatment of ventilation	through study completion, an average of 1 year
Primary	direct medical cost	direct medical cost	through study completion, an average of 1 year
Primary	proportion of different virus genotype	virus genotype include A, B and C	through study completion, an average of 1 year
Primary	F protein gene sequence	F protein gene sequence	through study completion, an average of 1 year
Primary	number of patients infected with bacteria	number of patients infected with bacteria	through study completion, an average of 1 year
Primary	number of patients infected with virus	number of patients infected with virus	through study completion, an average of 1 year
Primary	number of patients infected with fungus	number of patients infected with fungus	through study completion, an average of 1 year