MEANING
BUrden of Disease and COst of illneSS for RSV and other pathogens in patients 60 years and older within the outpatient setting
BACKGROUND
The Respiratory Syncytial Virus (RSV) is a pathogen causing upper and lower airway infections including pneumonia. While RSV infections are reported for all age groups, it is most common among young children, with a high risk for complications in prematurely born children and children with pulmonary or cardiac comorbidities. However, infection of adults can lead to severe disease progression. Here, the epidemiology and burden of disease are under researched. It is known that particularly older patients above 60 years bear a higher mortality risk akin to that of influenza infection. Possibly, comorbidities contribute to this increased risk of RSV infection in the elderly.
Besides evaluation of epidemiology and risk factors, also prevention and therapy strategies are investigated. This includes the vaccination against RSV as well as against other viral pathogens of the respiratory tract, and the effectivity and safety of novel therapeutic measures.
As a further factor, RSV infection is put into context with socioeconomic aspects and the quality of life of the patient. All aspects of the study combined can evaluate the burden of the RSV-mediated disease in the elderly population in Germany.
STUDIE OBJECTIVES
The BUCOSS study gathers information on RSV infections among adults beyond 60 years focusing on
- Description of the frequency of viral disease among ambulatory cases of airway infections
- The prevalence of RSV among these cases
- Description of co-infections of other viral or bacterial pathogens with RSV
- Description of symptoms and a typical course of disease
- Description of complications and hospitalization rate
- Description of demographic and socioeconomic factors contribution to quality of life and evaluation of quality of health of the patient as well as burden on the health care system
TIME FRAME
- 3 RSV seasons (winters) starting 2022/23 October- April.
- Observational time per patient: 28 days
NUMBER OF STUDY PARTICIPANTS
recruitment of altogether 3000 patients is planned over a total of 3 RSV seasons
PATIENT PROFILE
Adults ≥ 60 years with symptoms of airway infection in the ambulatory sector
STUDY LOCATIONS
10-15 offices of general or specialist practitioners
TYPO OF STUDY
prospective, multi-central, observational study; active surveillance study in the ambulatory sector
ROLE OF CAPNETZ: EXECUTION OF PROPRIETARY STUDY
The BUCOSS study is a study designed and executed by the CAPNETZ STIFTUNG in frame of the mission of the foundation and in line with pressing current scientific questions. For this, CAPNETZ has secured funding from GlaxoSmithKline as industrial partner.
Study execution is directed and data is managed at the CAPNETZ STIFTUNG headquarters. For this, the established CAPNETZ study infrastructure is used and applied onto the network of ambulatory clinical centres of the BUCOSS study for patient recruitment and data collection. Viral diagnostics is operated by the Institute of Virology of the University Medical Centre Freiburg. The scientific lead of the BUCOSS study is Prof Gernot Rohde from the Pulmonology Department of the University Medical Centre Frankfurt/Main.
For evalulation of data CAPNETZ foundation cooperates with Epidemiologist Prof Roland Diel and Statistician Dr Paul Schmidt. Results dissemination is organized by CAPNETZ STIFTUNG.
The electronic study management system (EDC) for central data collection is developed and supported by Webspirit Systems GmbH. The long-time cooperation with the managing director Torsten Illmann started in 2001 when the CAPNETZ study management system was developed at the University of Ulm. Webspirit System GmbH operates in the field of clinical research and has been ISO-9001 certified since 2023.
