Genotype and Disease Burden of RSV in Older Vietnamese Adults (RSV: Respiratory Syncytial Virus )

NCT07239583 | Recruiting

• 1 other identifier: TA-0003
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This observational, prospective, multicenter study aims to estimate the proportion of RSV infection in adults aged 60 years and older hospitalized due to acute respiratory infections or exacerbation of cardiopulmonary disease.

Conditions

Respiratory Syncytial Virus Infection; Respiratory Syncytial Virus Infections

Keywords

Respiratory Syncytial Virus (RSV); Acute Respiratory Infection (ARI); Metagenomic Sequencing (mNGS); RSV Genotype; Disease Severity; Healthcare Resource Utilization

Outcome Measures

Primary Outcomes (1)

• The proportion of RSV infection in adults aged 60 years and older hospitalized due to acute respiratory infections or exacerbation of cardiopulmonary disease.

  The proportion of participants with laboratory-confirmed RSV infection (including RSV A and RSV B) among adults aged ≥60 years hospitalized for acute respiratory infection or cardiopulmonary disease exacerbation. Diagnosis will be based on qualitative PCR results from nasopharyngeal or sputum samples.

  Within 24 hours after hospital admission

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized adults aged ≥60 years with acute respiratory infections at Tam Anh TP. Ho Chi Minh General Hospital and Tam Anh General Hospital

You may qualify if:

• Individuals ≥ 60 years old at the time of screening (calculated from the date of birth to the date of screening)
• ARI or exacerbation of cardiopulmonary diseases diagnosed at the time of admission. ARI or ARI-compatible symptoms were defined as either:
• New onset or increase from baseline of: nasal congestion, rhinorrhea, sore throat, hoarseness, cough, sputum production, dyspnea, wheezing, hypoxemia, or
• Admitting diagnosis suggestive of ARI (e.g., pneumonia, upper respiratory infection, bronchitis, influenza, cough, viral respiratory illness, respiratory distress, or respiratory failure), or
• Admitting diagnosis was the exacerbation of an underlying cardiac or pulmonary disease involving acute respiratory symptoms within the previous 2 weeks (e.g., congestive heart failure \[CHF\], chronic obstructive pulmonary disease \[COPD\], or asthma exacerbation).
• The participant agrees to voluntarily participate in this study.

You may not qualify if:

• Symptom onset \> 6 days prior to screening date
• Acute symptoms confirmed to be unrelated to infection or as assessed by the investigator
• Admission to any hospital within the 30 days preceding the screening date
• Previously enrolled in the study in the last 45 days

Sponsors & Collaborators

• Tam Anh Research Institute: lead

Study Sites (1)

Tam Anh TP. Ho Chi Minh General Hospital

Ho Chi Minh City, Southern Vietnam, 700000, Vietnam

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal and sputum samples stored at -70°C for viral PCR and metagenomic sequencing; no human DNA extracted.

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

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

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)