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Respiratory Syncytial Virus (RSV) InfectionNCT07015255

Assessing the Burden of Respiratory Syncytial Virus (RSV)

An observational study of Respiratory Syncytial Virus (RSV) Infection and Acute Lower Respiratory Tract Infections, run by Abu Dhabi Health Services Company at 1 site in United Arab Emirates.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study examines the impact of Respiratory Syncytial Virus (RSV) on people of all ages, from infants to the elderly. It uses hospital records collected between January 2018 and December 2024 to understand: How often does RSV occur Who is most at risk The long-term and financial effects of RSV Read more about this study

Who is it for?
Any age
How many people
1,500 participants
Where
1 siteUnited Arab Emirates
Study dates
Jun 2025to Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: This study includes all patients of any age who have a laboratory-confirmed diagnosis of Respiratory Syncytial Virus (RSV) infection recorded in the SEHA electronic medical records between January 2018 and December 2024. The population spans from newborn infants to elderly adults, including those with underlying medical conditions such as chronic lung disease, heart disease, immunosuppression, and other comorbidities that may influence RSV severity. Both hospitalized patients and those diagnosed in outpatient settings within SEHA healthcare facilities are included. The study aims to represent the full spectrum of RSV disease burden, clinical outcomes, risk factors, long-term health impacts, and healthcare costs across diverse demographic groups in the UAE.

Who may be able to join

  • Patients of all ages with a confirmed diagnosis of RSV infection
  • Patients admitted to a SEHA hospital or healthcare facility between January 2018 and December 2024
  • Patients with documented data in the SEHA electronic medical record (EMR) system

Who cannot join

  • Patients with suspected RSV infection that is not laboratory-confirmed
  • Patients without sufficient data in the SEHA EMR system

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lina Khairy, MD contact

+971589111897

o-lkhayri@seha.ae

Alina Naeem, MBBS, MS contact

+971566089799

alina.naeem@purehealth.ae

United Arab Emirates1 site

  • Sheikh Khalifa Medical City (Abu Dhabi Health Research Centre), SEHA

    Abu Dhabi

Other trials in United Arab Emirates

About this study

Official title: Assessing the Burden of Respiratory Syncytial Virus (RSV): the Assessment of the Burden of Respiratory Syncytial Virus (RSV) Across Different Age Groups and Risk Factors

This study examines the impact of Respiratory Syncytial Virus (RSV) on people of all ages, from infants to the elderly. It uses hospital records collected between January 2018 and December 2024 to understand:

  • How often does RSV occur
  • Who is most at risk
  • The long-term and financial effects of RSV
Read the detailed description

This study is designed to analyze the impact of Respiratory Syncytial Virus (RSV) across different age groups. It focuses on how often RSV occurs, who is most at risk, and its long-term and financial effects. The study uses existing hospital records from SEHA facilities between January 2018 and December 2024. This is a retrospective observational study, meaning no new tests or treatments are given. Researchers look at medical records from past patients who were diagnosed with RSV. Anonymized data is collected from SEHA's Electronic Medical Records (EMR) and laboratory systems. Only patients with confirmed RSV infections are included.

Keywords
Respiratory Syncytial Virus, RSV, RSV Infection, RSV in Infants, RSV in Adults, RSV Hospitalization, RSV Epidemiology, RSV Burden, RSV Risk Factors, Retrospective Study, Observational Study, ICU Admissions, RSV Mortality, RSV Cost Analysis, RSV Complications, Asthma and RSV, Bronchiolitis, Pneumonia, Recurrent Wheezing, RSV Surveillance
Medical subject headings
Infections, Bronchiolitis, Pneumonia, Respiratory Syncytial Virus Infections, Asthma, Respiratory Sounds

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07015255
Study groupRoleWhat they receive
Infants, adults, elderly, and high-risk patients with confirmed RSV infection (2018-2024).This retrospective study includes patients of all ages with confirmed Respiratory Syncytial Virus (RSV) infection from January 2018 to December 2024, categorized into four cohorts: (1) Infants and young children, including those with risk factors such as prematurity, low birth weight, and chronic lung or heart disease; (2) Adults aged 18-64 years with or without comorbidities; (3) Elderly adults aged 65 and older, with focus on severe outcomes and mortality; and (4) High-risk individuals across all age groups with underlying conditions such as asthma, COPD, diabetes, immunosuppression, Down syndrome, or cystic fibrosis. No interventions are administered; the study analyzes existing data to assess RSV burden, ICU admissions, long-term health impacts, and associated healthcare costs.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Burden of RSV Infection Across All Age Groups

    Measurement of the incidence of confirmed RSV infections in patients of all ages using SEHA hospital data from January 2018 to December 2024.

    Measured: January 2018 - December 2024

  2. Burden of RSV Infection Across All Age Groups

    Measurement of the prevalence of confirmed RSV infections in patients of all ages using SEHA hospital data from January 2018 to December 2024.

    Measured: January 2018 - December 2024

Secondary outcomes (7)

  1. Identification of Risk Factors for Severe RSV Infection

    Analysis of clinical, demographic, and comorbidity data to identify key risk factors associated with severe RSV infection outcomes.

    Measured: January 2018 - December 2024

  2. Proportion of Hospital Admissions Due to RSV

    Evaluation of the percentage of total hospital admissions attributed to RSV infections.

    Measured: January 2018 - December 2024

  3. ICU Admission Rates for RSV-Infected Patients

    Measurement of the proportion of RSV patients requiring ICU care.

    Measured: January 2018 - December 2024

  4. Financial Burden of RSV Infection

    Assessment of direct medical costs associated with RSV hospitalization and ICU care.

    Measured: January 2018 - December 2024

  5. Incidence of Recurrent Wheezing and Asthma Diagnosis Following RSV Infection

    Evaluation of long-term respiratory complications, specifically:

    1. Clinically diagnosed asthma using standardized clinical criteria (e.g., based on ICD-10 codes or physician diagnosis recorded in medical records)
    2. Recurrent wheezing episodes, defined as ≥3 wheezing episodes confirmed by clinical examination or parent report within 12 months post-infection, assessed via structured caregiver questionnaires and medical record review.

    Measured: Up to 12 months post-infection

  6. RSV-Associated Mortality Rates

    Analysis of death rates among RSV-positive patients, including 30-day mortality post-admission.

    Measured: January 2018 - December 2024

  7. Long-Term Respiratory Outcomes Following RSV Infection

    Evaluation of post-RSV respiratory complications such as asthma and recurrent wheezing.

    Measured: Up to 12 months post-infection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

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
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07015255
Sponsor's protocol ID
DOH/ADHRTC/2025/361
Status last verified
Jun 2025
First submitted
16 May 2025
Last updated
19 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Felton DA. A time of 'firsts'. J Prosthodont. 2004 Mar;13(1):1-2. doi: 10.1111/j.1532-849X.2004.04011.x. No abstract available.

    PubMed 15032890

  • Zhou H, Thompson WW, Viboud CG, Ringholz CM, Cheng PY, Steiner C, Abedi GR, Anderson LJ, Brammer L, Shay DK. Hospitalizations associated with influenza and respiratory syncytial virus in the United States, 1993-2008. Clin Infect Dis. 2012 May;54(10):1427-36. doi: 10.1093/cid/cis211. Epub 2012 Apr 10.

    PubMed 22495079

  • Hall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, Staat MA, Auinger P, Griffin MR, Poehling KA, Erdman D, Grijalva CG, Zhu Y, Szilagyi P. The burden of respiratory syncytial virus infection in young children. N Engl J Med. 2009 Feb 5;360(6):588-98. doi: 10.1056/NEJMoa0804877.

    PubMed 19196675

  • Wassmer SC, Lepolard C, Traore B, Pouvelle B, Gysin J, Grau GE. Platelets reorient Plasmodium falciparum-infected erythrocyte cytoadhesion to activated endothelial cells. J Infect Dis. 2004 Jan 15;189(2):180-9. doi: 10.1086/380761. Epub 2004 Jan 9.

    PubMed 14722881

  • Callen A, Diener-West M, Zeitlin PL, Rubenstein RC. A simplified cyclic adenosine monophosphate-mediated sweat rate test for quantitative measure of cystic fibrosis transmembrane regulator (CFTR) function. J Pediatr. 2000 Dec;137(6):849-55. doi: 10.1067/mpd.2000.109198.

    PubMed 11113843

  • Falsey AR, Hennessey PA, Formica MA, Cox C, Walsh EE. Respiratory syncytial virus infection in elderly and high-risk adults. N Engl J Med. 2005 Apr 28;352(17):1749-59. doi: 10.1056/NEJMoa043951.

    PubMed 15858184

  • Joury J, Al Kaabi N, Al Dallal S, Mahboub B, Zayed M, Abdelaziz M, Onwumeh-Okwundu J, Fletcher MA, Kumaresan S, Ramachandrachar BC, Farghaly M. Retrospective Analysis of RSV Infection in Pediatric Patients: Epidemiology, Comorbidities, Treatment, and Costs in Dubai (2014-2023). J Health Econ Outcomes Res. 2024 Nov 5;11(2):133-144. doi: 10.36469/001c.123889. eCollection 2024.

    PubMed 39575134

  • Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1;375(9725):1545-55. doi: 10.1016/S0140-6736(10)60206-1.

    PubMed 20399493

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Syncytial Virus (RSV) Infection and Acute Lower Respiratory Tract Infections, run by Abu Dhabi Health Services Company at 1 site in United Arab Emirates.

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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 19 Jun 2025. 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 United Arab Emirates. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lina Khairy, MD (+971589111897, o-lkhayri@seha.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Burden of RSV Infection Across All Age Groups (time frame: January 2018 - December 2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07015255, which also lists 8 linked publications.

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 19 Jun 2025.

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