Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
209 participants
OBSERVATIONAL
2017-04-01
2023-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Laboratory-confirmed RSV positivity via multiplex PCR
* Hospitalized for acute lower respiratory tract infection
* Complete hospitalization and clinical data available
Exclusion Criteria
* Discharge against medical advice before treatment was completed
* Missing or incomplete key clinical, laboratory, or radiologic data
* ICU admission without full follow-up data
1 Month
24 Months
ALL
No
Sponsors
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Dr. Behcet Uz Children's Hospital
OTHER
Responsible Party
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Burcu Busra Acar
Pediatric Cardiology Fellow, Ege University Faculty of Medicine
Principal Investigators
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Burcu Büşra B Acar, Pediatric Cardiology Fellow
Role: PRINCIPAL_INVESTIGATOR
Ege University
Burcu Büşra B Acar, Pediatric Cardiology Fellow
Role: PRINCIPAL_INVESTIGATOR
Ege University Faculty of Medicine, Department of Pediatric Cardiology
Locations
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Dr. Behçet Uz Children's Hospital
Izmir, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-634
Identifier Type: -
Identifier Source: org_study_id
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