RSV Antibiotic Drivers And Resource-use

NCT06977971 | Completed

• 1 other identifier: 2021-634
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Respiratory Syncytial Virus Infections; Antibiotic Stewardship in Community Hospitals

Keywords

Respiratory Syncytial Virus Infections; Anti-Bacterial Agents; Health Care Costs; Polymerase Chain Reaction; C-Reactive Protein

Outcome Measures

Primary Outcomes (1)

• 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.

  During hospitalization (April 2017 - April 2021)

Secondary Outcomes (1)

• Total antibiotic-related hospitalization cost per patient

  During hospitalization (April 2017 - April 2021)

Study Arms (1)

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.

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead

Study Sites (1)

Dr. Behçet Uz Children's Hospital

Izmir, 35220, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Burcu Büşra B Acar, Pediatric Cardiology Fellow

  Ege University

  PRINCIPAL INVESTIGATOR

• Burcu Büşra B Acar, Pediatric Cardiology Fellow

  Ege University Faculty of Medicine, Department of Pediatric Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Cardiology Fellow, Ege University Faculty of Medicine

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 18, 2025
• Study Start: April 1, 2017
• Primary Completion: April 1, 2021
• Study Completion: October 1, 2023
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)