Clinical trial NCT06977971: RSV Antibiotic Drivers And Resource-use
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Dr. Behcet Uz Children's Hospital
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 209
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Association between clinical/laboratory/radiologic parameters and antibiotic prescription
timeFrame: During hospitalization (April 2017 - April 2021)
Secondary outcomes:
measure: Total antibiotic-related hospitalization cost per patient
timeFrame: During hospitalization (April 2017 - April 2021)
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dr. Behçet Uz Children's Hospital
Study officials:
affiliation: Ege University
name: Burcu Büşra B Acar, Pediatric Cardiology Fellow
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University Faculty of Medicine, Department of Pediatric Cardiology
name: Burcu Büşra B Acar, Pediatric Cardiology Fellow
role: PRINCIPAL_INVESTIGATOR
References: