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.
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
- Conditions the study is for
- Respiratory Syncytial Virus (RSV) Infection, Acute Lower Respiratory Tract Infections, Bronchiolitis
- How many people
- 1,500 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- Jun 2025to Jun 2026
- Phase
- Observational
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.
United Arab Emirates1 site
Sheikh Khalifa Medical City (Abu Dhabi Health Research Centre), SEHA
Abu Dhabi
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.
- Conditions
- Respiratory Syncytial Virus (RSV) Infection, Acute Lower Respiratory Tract Infections, Bronchiolitis, Pneumonia, Chronic Respiratory Conditions
- 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 group | Role | What 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.
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
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)
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
Proportion of Hospital Admissions Due to RSV
Evaluation of the percentage of total hospital admissions attributed to RSV infections.
Measured: January 2018 - December 2024
ICU Admission Rates for RSV-Infected Patients
Measurement of the proportion of RSV patients requiring ICU care.
Measured: January 2018 - December 2024
Financial Burden of RSV Infection
Assessment of direct medical costs associated with RSV hospitalization and ICU care.
Measured: January 2018 - December 2024
Incidence of Recurrent Wheezing and Asthma Diagnosis Following RSV Infection
Evaluation of long-term respiratory complications, specifically:
- Clinically diagnosed asthma using standardized clinical criteria (e.g., based on ICD-10 codes or physician diagnosis recorded in medical records)
- 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
RSV-Associated Mortality Rates
Analysis of death rates among RSV-positive patients, including 30-day mortality post-admission.
Measured: January 2018 - December 2024
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.
- First posted11 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus (RSV) InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Abu Dhabi Health Services Company
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Salah Eldin Hussein, MD, Study director, Abu Dhabi Health Services Company-SEHANawal Alkaabi, MD, Principal investigator, Abu Dhabi Health Services Company-SEHA
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 15032890Zhou 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 22495079Hall 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 19196675Wassmer 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 14722881Callen 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 11113843Falsey 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 15858184Joury 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 39575134Nair 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