RSV Antibiotic Drivers And Resource-use

NCT ID: NCT06977971

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2023-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Syncytial Virus Infections Antibiotic Stewardship in Community Hospitals

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Month

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dr. Behcet Uz Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Burcu Busra Acar

Pediatric Cardiology Fellow, Ege University Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Explore where the study is taking place and check the recruitment status at each participating site.

Dr. Behçet Uz Children's Hospital

Izmir, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-634

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Disease Burden of RSV
NCT05506670 COMPLETED NA
Transplacental Transmission of RSV (TTRSV)
NCT05443607 ACTIVE_NOT_RECRUITING