Study identification

EU PAS number

EUPAS1000000487

Study ID

1000000487

Official title and acronym

Epidemiology of Respiratory Syncytial Virus Infections: Retrospective Data to Estimate the Disease Burden in Turkiye

DARWIN EU® study

No

Study countries

Türkiye

Study description

Respiratory syncytial virus (RSV) is a major cause of hospitalisation in newborns, but the risk of infection remains for all children.
In Turkey, where the annual neonatal cohort is approximately 1,079,000, including 149,000 infants with prematurity or comorbid conditions, data on RSV incidence remains scarce.
Even though 98.5% of the population is covered by Social Security Insurance (SSI) and most childhood vaccines are included in the National Immunisation Programme (NIP), public health policy on RSV remains limited due to gaps in real-world data.

Currently, the hospitalisation rate for RSV-positive lower respiratory tract infection (LRTI) is estimated at 7.8 per 1000 infants based on one study. However, the outpatient burden is unknown because RSV testing is not covered in public hospitals, hindering proper diagnosis and surveillance. The lack of data also affects prevention strategies - although palivizumab is available, reimbursement is limited to certain high-risk groups, potentially underestimating the true burden of RSV hospitalisations and associated healthcare costs.

This study aims to fill these data gaps by providing comprehensive epidemiological information on RSV in both inpatient and outpatient settings. A clearer understanding of the morbidity, mortality, and direct costs associated with RSV will facilitate evidence-based policy decisions, helping clinicians and policymakers better evaluate prevention strategies.

With robust real-world data, this study will contribute to the discussion on the expansion of RSV prevention programmes under the NIP in Turkey and serve as a model for other countries in Eurasia to develop national recommendations for RSV prevention.

Study status

Finalised
Research institutions and networks

Institutions

Traverse Health
Acıbadem Mehmet Ali Aydinlar University

Contact details

Metehan Ozen 0000-0003-4088-3103

Primary lead investigator
ORCID number:
0000-0003-4088-3103
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

This study was sponsored by Sanofi
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable