RSV strains and illness burden in Vietnamese adults aged 60 and older

A Description of the Proportion, Genotype Distribution of Respiratory Syncytial Virus and the Severity of Disease in Hospitalized Elderly in Vietnam

This project will test how common RSV is and which strains and severity patterns occur in people aged 60+ who are hospitalized with acute respiratory illness or worsening heart/lung disease.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Tam Anh Research Institute (other)
• Locations: 1 site (Ho Chi Minh City, Southern Vietnam)
• Trial ID: NCT07239583 on ClinicalTrials.gov

What this trial studies

This is a prospective, observational, multicenter enrollment of about 1,000 patients aged 60 years and older admitted with acute respiratory infection (ARI) or exacerbation of chronic cardiopulmonary disease at two Tam Anh hospitals in Ho Chi Minh City. Participants will be screened consecutively, provide consent, and have demographic, clinical, and laboratory data collected from interviews and medical records; respiratory samples will be obtained within 24 hours of admission. Laboratory testing including metagenomic sequencing and viral load measurement will identify RSV infections, genotypes, and co-infections with influenza or SARS‑CoV‑2. Analyses are primarily descriptive, with comparisons between RSV and non‑RSV cases and exploratory modelling (logistic regression and Bayesian Model Averaging) to identify predictors of severe RSV outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 60 years or older who are admitted to the participating Tam Anh hospitals with ARI or an acute exacerbation of chronic cardiopulmonary disease and who can provide written informed consent.

Not a fit: People younger than 60, outpatients, those admitted for non‑respiratory reasons, or those in settings outside the participating hospitals are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could clarify how often RSV causes severe illness in older Vietnamese adults and which virus strains are circulating, informing local prevention and treatment planning.

How similar studies have performed: Similar hospital‑based RSV surveillance and sequencing studies in other countries have successfully described burden and genotypes, but large prospective mNGS-based datasets in older adults from Vietnam are limited.

Eligibility criteria

Inclusion Criteria:

To be enrolled in the study, participants must meet all inclusion criteria:

1. Individuals ≥ 60 years old at the time of screening (calculated from the date of birth to the date of screening)
2. 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).
3. The participant agrees to voluntarily participate in this study.

Exclusion Criteria:

To be enrolled in the study, participants must have none of the exclusion criteria:

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

Where this trial is running

Ho Chi Minh City, Southern Vietnam

• Tam Anh TP. Ho Chi Minh General Hospital — Ho Chi Minh City, Southern Vietnam, Vietnam (RECRUITING)

Conditions: Respiratory Syncytial Virus Infection, Respiratory Syncytial Virus Infections, Respiratory Syncytial Virus, Acute Respiratory Infection, Metagenomic Sequencing, RSV Genotype, Disease Severity, Healthcare Resource Utilization