Respiratory Syncytial Virus InfectionTRUST-RSVNCT07346963
RSV-Positive Children <5 Years Presenting to Pediatric Emergency Departments in Türkiye: TRUST-RSV
An observational study of Respiratory Syncytial Virus Infection and Acute Bronchiolitis Due to Respiratory Syncytial Virus, run by Eskisehir Osmangazi University.
Trial summary
Respiratory syncytial virus (RSV) is a leading cause of acute lower respiratory tract infection in infants and young children and contributes substantially to pediatric emergency department (ED) visits and hospitalizations. Read more about this study
- Who is it for?
- Ages 28 days to 5 years
- Conditions the study is for
- Respiratory Syncytial Virus Infection, Acute Bronchiolitis Due to Respiratory Syncytial Virus, Pneumonia
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jun 2027
- How long will I take part?
- 30 Days
- 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 28 days to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of children aged <5 years presenting to participating pediatric emergency departments in Türkiye during consecutive RSV season (2025-2026 ) who have respiratory syncytial virus (RSV) infection confirmed from a nasopharyngeal specimen using rapid antigen testing and/or PCR according to local site capacity and standard clinical practice. Eligible participants include RSV-positive children evaluated for compatible clinical diagnoses at presentation (e.g., upper respiratory tract infection, bronchiolitis, pneumonia, apnea, seizure/convulsion, or myocarditis). Enrollment requires written informed consent from a parent or legal guardian; children are excluded only if consent is declined. Clinical management is not assigned by the protocol and follows routine care; participants are observed for outcomes during the index emergency department encounter and, when applicable, through the index hospitalization.
Who may be able to join
- Age <5 years at presentation
- Presentation during RSV season (2025-2026 )
- RSV infection confirmed from a nasopharyngeal sample by rapid antigen test or PCR according to site capacity
- Presentation to a participating pediatric ED with at least one of the following clinical diagnoses: upper respiratory tract infection, bronchiolitis, pneumonia, apnea, seizure/convulsion, or myocarditis
- Written informed consent obtained from a parent or legal guardian.
Who cannot join
- Parent or legal guardian declines consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Demographic, Clinical, and Healthcare Utilization Characteristics of Respiratory Syncytial Virus (RSV) Positive Cases Under 5 Years Presenting to Pediatric Emergency Departments in Türkiye: A Multicenter, Prospective Observational Study (TRUST-RSV)
Respiratory syncytial virus (RSV) is a leading cause of acute lower respiratory tract infection in infants and young children and contributes substantially to pediatric emergency department (ED) visits and hospitalizations. In Türkiye, nationally representative prospective data describing the epidemiology, clinical spectrum, and resource utilization of RSV-positive children presenting to pediatric EDs remain limited. This multicenter prospective observational study aims to characterize demographic and clinical features of RSV-positive children under 5 years of age presenting to participating pediatric EDs across two consecutive RSV seasons, and to quantify key healthcare utilization outcomes, including ED observation duration, hospitalization, and intensive care unit (ICU) admission.
Read the detailed description
This is a multicenter, prospective observational cohort study conducted in pediatric emergency departments in Türkiye over a consecutive RSV season. Eligible participants are children younger than 5 years who present to a participating pediatric ED with at least one compatible clinical diagnosis and have RSV infection confirmed by a nasopharyngeal sample using either a rapid antigen test or PCR, based on local site capacity. Written informed consent will be obtained from a parent or legal guardian prior to study procedures.
Standardized case report forms will be used to collect demographics (age, sex, region, socioeconomic indicators), relevant risk factors (e.g., prematurity, congenital heart disease, chronic lung disease, passive smoke exposure, breastfeeding status), presenting symptoms, vital signs and physical examination findings, diagnostic evaluations (radiology and laboratory results as available), and clinical management and outcomes. Outcomes of interest include ED observation duration, disposition (discharge vs hospitalization), ICU admission, and, when applicable, the need for oxygen or ventilatory support. Data will be entered into a secure centralized database. The study will evaluate seasonal and regional patterns and will explore predictors of severe outcomes among RSV-positive children using multivariable models.
- Conditions
- Respiratory Syncytial Virus Infection, Acute Bronchiolitis Due to Respiratory Syncytial Virus, Pneumonia, Upper Respiratory Tract Infection
- Keywords
- pediatric emergency department, multicenter, prospective, healthcare utilization
- Medical subject headings
- Respiratory Syncytial Virus Infections, Pneumonia, Respiratory Tract Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization rate
Proportion of children with laboratory-confirmed RSV infection presenting to participating pediatric EDs who are hospitalized from the index ED encounter. "Hospitalized" is defined as admission from the ED to an inpatient unit (ward) or intensive care unit (ICU) immediately following ED evaluation; children discharged home are classified as not hospitalized.
Measured: Index ED visit (from ED presentation/triage to ED disposition decision and departure from the ED for inpatient admission or discharge), up to 24 hours.
ICU admission rate among hospitalized RSV-positive children
Proportion of hospitalized children with laboratory-confirmed RSV infection who require admission to an intensive care unit (ICU) at any time during the index hospitalization. ICU admission is defined as transfer from the ED or inpatient ward to an ICU for higher-level monitoring and/or organ support.
Measured: During the index hospitalization, from hospital admission to hospital discharge, up to 24 hours.
Need for respiratory support among RSV-positive children
Proportion of RSV-positive children who receive any respiratory support documented in the medical record, including supplemental oxygen (any delivery method) and/or noninvasive ventilation (e.g., HFNC/CPAP/BiPAP per local practice) and/or invasive mechanical ventilation.
Measured: From hospital admission to hospital discharge during the index hospitalization, up to 24 hours.
Secondary outcomes (3)
ED length of stay (ED observation duration) among RSV-positive children
Time from ED arrival/registration (or triage time, per site practice) to ED disposition, defined as discharge home or departure from the ED for inpatient admission. Duration will be reported in hours.
Measured: Index ED visit (from ED arrival/registration or triage to ED disposition and ED departure), up to 24 hours.
Occurrence of RSV-associated complications during the index visit
Presence of pre-specified complications documented during the index ED visit and/or hospitalization (e.g., apnea requiring intervention, seizure/convulsion, myocarditis, suspected bacterial co-infection, or other clinically documented complications).
Measured: From ED arrival to hospital discharge, up to 24 hours.
Diagnostic evaluations performed during the index visit
Proportion of participants who undergo any diagnostic evaluation during the index visit as documented in the medical record and recorded in the study database. Diagnostic evaluations include, but are not limited to, chest radiography and laboratory testing performed in accordance with the standard of care.
Measured: From ED arrival/registration (or triage) through hospital discharge for the index episode of care, up to 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus 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
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Güngör, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346963
- Sponsor's protocol ID
- TRUST-RSV-v001
- Other IDs
- 2025-16
- Acronym
- TRUST-RSV
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study was not designed with an IPD-sharing plan in place, and the current ethics approvals and informed consent documents do not include provisions for public IPD sharing.
Publications
Del Riccio M, Spreeuwenberg P, Osei-Yeboah R, Johannesen CK, Fernandez LV, Teirlinck AC, Wang X, Heikkinen T, Bangert M, Caini S, Campbell H, Paget J; RESCEU Investigators. Burden of Respiratory Syncytial Virus in the European Union: estimation of RSV-associated hospitalizations in children under 5 years. J Infect Dis. 2023 Nov 28;228(11):1528-1538. doi: 10.1093/infdis/jiad188.
PubMed 37246724McMorrow ML, Moline HL, Toepfer AP, Halasa NB, Schuster JE, Staat MA, Williams JV, Klein EJ, Weinberg GA, Clopper BR, Boom JA, Stewart LS, Selvarangan R, Schlaudecker EP, Michaels MG, Englund JA, Albertin CS, Mahon BE, Hall AJ, Sahni LC, Curns AT. Respiratory Syncytial Virus-Associated Hospitalizations in Children <5 Years: 2016-2022. Pediatrics. 2024 Jul 1;154(1):e2023065623. doi: 10.1542/peds.2023-065623.
PubMed 38841769
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Demographic, Clinical, and Healthcare Utilization Characteristics of Respiratory Syncytial Virus (RSV) Positive Cases Under 5 Years Presenting to Pediatric Emergency Departments in Türkiye: A Multicenter, Prospective Observational Study (TRUST-RSV)
- ClinicalTrials.gov ID
- NCT07346963
- Acronym / sponsor ID
- TRUST-RSV / TRUST-RSV-v001
- Conditions
- Respiratory Syncytial Virus Infection, Acute Bronchiolitis Due to Respiratory Syncytial Virus, Pneumonia, Upper Respiratory Tract Infection
- Keywords
- pediatric emergency department, multicenter, prospective, healthcare utilization
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Respiratory syncytial virus (RSV) is a leading cause of acute lower respiratory tract infection in infants and young children and contributes substantially to pediatric emergency department (ED) visits and hospitalizations. In Türkiye, nationally representative prospective data describing the epidemiology, clinical spectrum, and resource utilization of RSV-positive children presenting to pediatric EDs remain limited. This multicenter prospective observational study aims to characterize demographic and clinical features of RSV-positive children under 5 years of age presenting to participating pediatric EDs across two consecutive RSV seasons, and to quantify key healthcare utilization outcomes, including ED observation duration, hospitalization, and intensive care unit (ICU) admission.
Detailed description
This is a multicenter, prospective observational cohort study conducted in pediatric emergency departments in Türkiye over a consecutive RSV season. Eligible participants are children younger than 5 years who present to a participating pediatric ED with at least one compatible clinical diagnosis and have RSV infection confirmed by a nasopharyngeal sample using either a rapid antigen test or PCR, based on local site capacity. Written informed consent will be obtained from a parent or legal guardian prior to study procedures.
Standardized case report forms will be used to collect demographics (age, sex, region, socioeconomic indicators), relevant risk factors (e.g., prematurity, congenital heart disease, chronic lung disease, passive smoke exposure, breastfeeding status), presenting symptoms, vital signs and physical examination findings, diagnostic evaluations (radiology and laboratory results as available), and clinical management and outcomes. Outcomes of interest include ED observation duration, disposition (discharge vs hospitalization), ICU admission, and, when applicable, the need for oxygen or ventilatory support. Data will be entered into a secure centralized database. The study will evaluate seasonal and regional patterns and will explore predictors of severe outcomes among RSV-positive children using multivariable models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 28 days to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of children aged <5 years presenting to participating pediatric emergency departments in Türkiye during consecutive RSV season (2025-2026 ) who have respiratory syncytial virus (RSV) infection confirmed from a nasopharyngeal specimen using rapid antigen testing and/or PCR according to local site capacity and standard clinical practice. Eligible participants include RSV-positive children evaluated for compatible clinical diagnoses at presentation (e.g., upper respiratory tract infection, bronchiolitis, pneumonia, apnea, seizure/convulsion, or myocarditis). Enrollment requires written informed consent from a parent or legal guardian; children are excluded only if consent is declined. Clinical management is not assigned by the protocol and follows routine care; participants are observed for outcomes during the index emergency department encounter and, when applicable, through the index hospitalization.
Key inclusion criteria (5 listed)
- Age <5 years at presentation
- Presentation during RSV season (2025-2026 )
- RSV infection confirmed from a nasopharyngeal sample by rapid antigen test or PCR according to site capacity
- Presentation to a participating pediatric ED with at least one of the following clinical diagnoses: upper respiratory tract infection, bronchiolitis, pneumonia, apnea, seizure/convulsion, or myocarditis
- Written informed consent obtained from a parent or legal guardian.
Key exclusion criteria (1 listed)
- Parent or legal guardian declines consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospitalization rate
Time frame: Index ED visit (from ED presentation/triage to ED disposition decision and departure from the ED for inpatient admission or discharge), up to 24 hours.
Proportion of children with laboratory-confirmed RSV infection presenting to participating pediatric EDs who are hospitalized from the index ED encounter. "Hospitalized" is defined as admission from the ED to an inpatient unit (ward) or intensive care unit (ICU) immediately following ED evaluation; children discharged home are classified as not hospitalized.
ICU admission rate among hospitalized RSV-positive children
Time frame: During the index hospitalization, from hospital admission to hospital discharge, up to 24 hours.
Proportion of hospitalized children with laboratory-confirmed RSV infection who require admission to an intensive care unit (ICU) at any time during the index hospitalization. ICU admission is defined as transfer from the ED or inpatient ward to an ICU for higher-level monitoring and/or organ support.
Need for respiratory support among RSV-positive children
Time frame: From hospital admission to hospital discharge during the index hospitalization, up to 24 hours.
Proportion of RSV-positive children who receive any respiratory support documented in the medical record, including supplemental oxygen (any delivery method) and/or noninvasive ventilation (e.g., HFNC/CPAP/BiPAP per local practice) and/or invasive mechanical ventilation.
3 secondary outcomes
ED length of stay (ED observation duration) among RSV-positive children
Time frame: Index ED visit (from ED arrival/registration or triage to ED disposition and ED departure), up to 24 hours.
Occurrence of RSV-associated complications during the index visit
Time frame: From ED arrival to hospital discharge, up to 24 hours.
Diagnostic evaluations performed during the index visit
Time frame: From ED arrival/registration (or triage) through hospital discharge for the index episode of care, up to 24 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Results publication: PubMed 37246724Del Riccio M, Spreeuwenberg P, Osei-Yeboah R, Johannesen CK, Fernandez LV, Teirlinck AC, Wang X, Heikkinen T, Bangert M, Caini S, Campbell H, Paget J; RESCEU Investigators. Burden of Respiratory Syncytial Virus in the European Union: estimation of RSV-associated hospitalizations in children under 5 years. J Infect Dis. 2023 Nov 28;228(11):1528-1538. doi: 10.1093/infdis/jiad188.
- Results publication: PubMed 38841769McMorrow ML, Moline HL, Toepfer AP, Halasa NB, Schuster JE, Staat MA, Williams JV, Klein EJ, Weinberg GA, Clopper BR, Boom JA, Stewart LS, Selvarangan R, Schlaudecker EP, Michaels MG, Englund JA, Albertin CS, Mahon BE, Hall AJ, Sahni LC, Curns AT. Respiratory Syncytial Virus-Associated Hospitalizations in Children <5 Years: 2016-2022. Pediatrics. 2024 Jul 1;154(1):e2023065623. doi: 10.1542/peds.2023-065623.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study was not designed with an IPD-sharing plan in place, and the current ethics approvals and informed consent documents do not include provisions for public IPD sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus Infection and Acute Bronchiolitis Due to Respiratory Syncytial Virus, run by Eskisehir Osmangazi University.
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 5 inclusion and 1 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Emre Güngör, M.D. (+905064255240, emre.gungor@ogu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization rate (time frame: Index ED visit (from ED presentation/triage to ED disposition decision and departure from the ED for inpatient admission or discharge), up to 24 hours.). The study lists 3 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 NCT07346963, which also lists 2 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 16 Jan 2026.