Respiratory Syncytial Virus InfectionsRADARNCT06977971
RSV Antibiotic Drivers And Resource-use
An observational study of Respiratory Syncytial Virus Infections and Antibiotic Stewardship in Community Hospitals, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study retrospectively evaluated the clinical, laboratory, and radiologic factors that influence the decision to prescribe antibiotics in children under 2 years of age hospitalized with RSV-positive acute lower respiratory tract infections. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Respiratory Syncytial Virus Infections, Antibiotic Stewardship in Community Hospitals
- How many people
- 209 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2017to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Hospitalized children aged 1 to 24 months with laboratory-confirmed RSV-positive acute lower respiratory tract infections, treated at Dr. Behçet Uz Children's Hospital between April 2017 and April 2021.
Who may be able to join
- Age between 1 and 24 months at the time of hospitalization
- Laboratory-confirmed RSV positivity via multiplex PCR
- Hospitalized for acute lower respiratory tract infection
- Complete hospitalization and clinical data available
Who cannot join
- Detection of additional respiratory pathogens on multiplex PCR
- Discharge against medical advice before treatment was completed
- Missing or incomplete key clinical, laboratory, or radiologic data
- ICU admission without full follow-up data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Behçet Uz Children's Hospital
Izmir, 35220
About this study
Official title: Evaluation of Clinical, Laboratory, and Radiologic Parameters Affecting Antibiotic Use and Associated Cost in RSV-Positive Children With Acute Lower Respiratory Tract Infections
This study retrospectively evaluated the clinical, laboratory, and radiologic factors that influence the decision to prescribe antibiotics in children under 2 years of age hospitalized with RSV-positive acute lower respiratory tract infections. The study also examined the economic impact of antibiotic use in these patients. The goal is to improve clinical decision-making and reduce unnecessary antibiotic exposure in children with viral infections.
Read the detailed description
This retrospective, single-center study aimed to assess the clinical decision-making process regarding antibiotic prescription in children aged 1 to 24 months hospitalized with RSV-positive acute lower respiratory tract infections (ALRTI). The study was conducted at Dr. Behçet Uz Children's Hospital and covered four consecutive RSV seasons (April 2017 - April 2021). RSV infection was confirmed via multiplex PCR.
Clinical and laboratory variables potentially influencing antibiotic use included fever, respiratory distress, CRP levels, leukocyte count, and radiologic findings such as infiltrates on chest X-ray. The study also examined whether antibiotic selection (agent, timing, and duration) was associated with specific clinical profiles or severity indicators.
Hospitalization cost data were analyzed to estimate the economic burden of antibiotic use in RSV-positive patients. The study contributes to improved antimicrobial stewardship by identifying patterns of potentially unnecessary antibiotic prescriptions in viral respiratory infections.
Ethical approval was obtained from the local ethics committee (Approval No: 2021-634), and the study adhered to the principles of the Declaration of Helsinki.
- Keywords
- Respiratory Syncytial Virus Infections, Anti-Bacterial Agents, Health Care Costs, Polymerase Chain Reaction, C-Reactive Protein
- Medical subject headings
- Respiratory Syncytial Virus Infections
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 |
|---|---|---|
| RSV-Positive Children Aged 1-24 Months | This cohort includes children aged 1 to 24 months who were hospitalized with laboratory-confirmed RSV-positive acute lower respiratory tract infections between April 2017 and April 2021. Data were collected retrospectively at Dr. Behçet Uz Children's Hospital. No intervention was administered as part of the study; the investigation focused on clinical, laboratory, and radiologic factors influencing antibiotic use, as well as associated hospitalization costs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between clinical/laboratory/radiologic parameters and antibiotic prescription
This outcome assesses the relationship between objective findings (e.g., CRP levels, abnormal chest X-ray, fever) and the decision to initiate antibiotic therapy in RSV-positive children aged 1-24 months hospitalized with acute lower respiratory tract infections.
Measured: During hospitalization (April 2017 - April 2021)
Secondary outcomes (1)
Total antibiotic-related hospitalization cost per patient
This outcome evaluates the economic impact of antibiotic use by calculating the direct hospitalization costs associated with antibiotic treatment in RSV-positive pediatric patients.
Measured: During hospitalization (April 2017 - April 2021)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Apr 2017
- Primary completion1 Apr 2021
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies 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
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Busra Acar, Dr. Behcet Uz Children's Hospital
- Investigators
- Burcu Büşra B Acar, Pediatric Cardiology Fellow, Principal investigator, Ege UniversityBurcu Büşra B Acar, Pediatric Cardiology Fellow, Principal investigator, Ege University Faculty of Medicine, Department of Pediatric Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977971
- Sponsor's protocol ID
- 2021-634
- Acronym
- RADAR
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is a retrospective observational analysis based on de-identified hospital records. Individual participant data will not be shared due to ethical considerations and the absence of participant consent for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical, Laboratory, and Radiologic Parameters Affecting Antibiotic Use and Associated Cost in RSV-Positive Children With Acute Lower Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT06977971
- Acronym / sponsor ID
- RADAR / 2021-634
- Keywords
- Respiratory Syncytial Virus Infections, Anti-Bacterial Agents, Health Care Costs, Polymerase Chain Reaction, C-Reactive Protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 18 May 2025 (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.
This study retrospectively evaluated the clinical, laboratory, and radiologic factors that influence the decision to prescribe antibiotics in children under 2 years of age hospitalized with RSV-positive acute lower respiratory tract infections. The study also examined the economic impact of antibiotic use in these patients. The goal is to improve clinical decision-making and reduce unnecessary antibiotic exposure in children with viral infections.
Detailed description
This retrospective, single-center study aimed to assess the clinical decision-making process regarding antibiotic prescription in children aged 1 to 24 months hospitalized with RSV-positive acute lower respiratory tract infections (ALRTI). The study was conducted at Dr. Behçet Uz Children's Hospital and covered four consecutive RSV seasons (April 2017 - April 2021). RSV infection was confirmed via multiplex PCR.
Clinical and laboratory variables potentially influencing antibiotic use included fever, respiratory distress, CRP levels, leukocyte count, and radiologic findings such as infiltrates on chest X-ray. The study also examined whether antibiotic selection (agent, timing, and duration) was associated with specific clinical profiles or severity indicators.
Hospitalization cost data were analyzed to estimate the economic burden of antibiotic use in RSV-positive patients. The study contributes to improved antimicrobial stewardship by identifying patterns of potentially unnecessary antibiotic prescriptions in viral respiratory infections.
Ethical approval was obtained from the local ethics committee (Approval No: 2021-634), and the study adhered to the principles of the Declaration of Helsinki.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RSV-Positive Children Aged 1-24 Months | – | –This cohort includes children aged 1 to 24 months who were hospitalized with laboratory-confirmed RSV-positive acute lower respiratory tract infections between April 2017 and April 2021. Data were collected retrospectively at Dr. Behçet Uz Children's Hospital. No intervention was administered as part of the study; the investigation focused on clinical, laboratory, and radiologic factors influencing antibiotic use, as well as associated hospitalization costs. |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Hospitalized children aged 1 to 24 months with laboratory-confirmed RSV-positive acute lower respiratory tract infections, treated at Dr. Behçet Uz Children's Hospital between April 2017 and April 2021.
Key inclusion criteria (4 listed)
- Age between 1 and 24 months at the time of hospitalization
- Laboratory-confirmed RSV positivity via multiplex PCR
- Hospitalized for acute lower respiratory tract infection
- Complete hospitalization and clinical data available
Key exclusion criteria (4 listed)
- Detection of additional respiratory pathogens on multiplex PCR
- Discharge against medical advice before treatment was completed
- Missing or incomplete key clinical, laboratory, or radiologic data
- ICU admission without full follow-up data
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
Association between clinical/laboratory/radiologic parameters and antibiotic prescription
Time frame: During hospitalization (April 2017 - April 2021)
This outcome assesses the relationship between objective findings (e.g., CRP levels, abnormal chest X-ray, fever) and the decision to initiate antibiotic therapy in RSV-positive children aged 1-24 months hospitalized with acute lower respiratory tract infections.
1 secondary outcome
Total antibiotic-related hospitalization cost per patient
Time frame: During hospitalization (April 2017 - April 2021)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No. This study is a retrospective observational analysis based on de-identified hospital records. Individual participant data will not be shared due to ethical considerations and the absence of participant consent for data 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. This study is not recruiting at the moment.
Burcu Büşra B Acar, Pediatric Cardiology Fellow principal investigator
Ege University
Burcu Büşra B Acar, Pediatric Cardiology Fellow principal investigator
Ege University Faculty of Medicine, Department of Pediatric Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus Infections and Antibiotic Stewardship in Community Hospitals, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 23 May 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between clinical/laboratory/radiologic parameters and antibiotic prescription (time frame: During hospitalization (April 2017 - April 2021)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2025.