Respiratory syncytial virus (RSV) is a leading cause of severe lower respiratory tract infection in young children, and a substantial proportion of severe cases occur in previously healthy infants. The gut-lung axis suggests that gut microbiome composition may modulate respiratory immune responses. This prospective observational study in Vietnam will compare gut microbiome profiles and systemic immune cytokine responses between infants with severe RSV infection and those with mild RSV infection, aiming to identify microbiome-immune signatures associated with disease severity.
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Infants with acute lower respiratory tract infection and RT-PCR-confirmed RSV presenting to Vietnam National Children's Hospital
Cohort
Prospective
Not listed
Association between gut microbiome diversity/composition and RSV severity
Differences in gut microbiome diversity and taxonomic composition assessed by 16S rRNA sequencing (alpha diversity, beta diversity, and differential taxa abundance) between severe and mild RSV groups
Systemic cytokine response in severe versus mild RSV infection
Serum concentrations of inflammatory and regulatory cytokines (TNF-α, IL-6, IL-8, IL-1β, IFN-γ, IL-10, IL-17A, IL-22) measured by ELISA All cytokines will be measured using the same assay platform and reported in the same unit of concentration. Unit of measurement is pg/ml
Clinical severity scores in RSV infection measured by Pediatric Sequential Organ Failure Assessment (pSOFA) Score
Clinical severity scores in RSV infection measured by Organ dysfunction severity assessed using the Pediatric Sequential Organ Failure Assessment (pSOFA) score (range: 0-24), with higher scores indicating more severe organ dysfunction
Integrated microbiome-immune signature predicting severe RSV
Multivariable model performance (AUC/ROC; or adjusted odds ratios for selected taxa + cytokines)
ICU resource utilization
ICU-free days: calculated as 28 minus ICU length of stay for patients discharged alive before Day 28; assigned 0 for patients who die before Day 28 or remain in ICU on/after Day 28. Ventilator-free days: calculated as 28 minus days of invasive mechanical ventilation for patients alive and ventilated \<28 days; assigned 0 for patients who die before Day 28 or remain ventilated on/after Day 28. Vasopressor-free days: calculated as 28 minus days receiving vasoactive agents for patients alive and requiring vasoactives \<28 days; assigned 0 for patients who die before Day 28 or remain on vasoactives on/after Day 28. Discontinuation requires ≥12 hours without vasoactive support
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Phuc Huu Phan
Lead sponsor
National Children's Hospital, Vietnam
Sponsor institution
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