
BUCOSS Hosp Study
The BUCOSS Hosp study is registered in the German Register of Clinical Studies under the DRKS ID of study DRKS00032893.

SIGNIFICANCE
BUrden of Disease and COst of illneSS for RSV and other pathogens among Hospitalized adults
Krankheitsbelastung und Kosten von Infektionen mit RSV (Respiratorisches Synzytial-Virus) und anderen viralen Erregern bei stationären erwachsenen Patienten

BACKGROUND
Infectious respiratory diseases are among the most common communicable diseases. The spectrum of viral pathogens ranges from rhinoviruses, influenza and SARS-CoV-2 to RSV (respiratory syncytial virus) and human metapneumovirus, which is very similar to the more common RSV. Depending on the characteristics of the patient, particularly age and the type of pathogen, respiratory infections can have very different individual outcomes, ranging from mild to fatal. In particular, viral infections of the lower respiratory tract, such as pneumonia, can lead to life-threatening pulmonary insufficiency. Septic shock with the risk of permanent organ damage is also possible.
For a long time, RSV infection was thought to be primarily a threat to infants and young children. However, it is now clear that it is not just children who are at risk. Two studies of the relationship between RSV infection and hospitalization have shown that older people over the age of sixty are also increasingly suffering from serious illnesses that require hospitalization – often with considerable risks: in a French study of hospitalized RSV-infected people over the age of sixty, the mortality rate was 6 percent. In another Belgian-French study, the mortality rate due to RSV infection in the intensive care unit was 23.9% for people of all ages, similar to the mortality rate for influenza.
The aim of the BUCOSS Hosp study is to assess the burden of disease in hospitalized adult patients with RSV and other viral respiratory infections, to describe risk factors for early identification of patients at risk, and to assess quality of life using a questionnaire one month after diagnosis.
Finally yet importantly, economic aspects should also be considered. The acute illness, its sequelae and limitations, and hospital care, represent a significant economic burden. While life-sustaining measures and many therapeutic agents are covered by health insurance, hospitalization and follow-up care are direct costs to the patient. How high are they? BUCOSS Hosp also wants to clarify this.

STUDY OBJECTIVES IN DETAIL
Primary study objectives
- Determine the prevalence of RSV in hospitalized patients with respiratory tract infections aged 50 years and older
- Determine the prevalence of RSV in hospitalized patients with respiratory tract infections aged 18 to 49 years
Secondary study objectives
- Determine of the prevalence of RSV in hospitalized patients with respiratory tract infections aged 18 years and older
- Estimate the seasonal incidence of respiratory tract infection-associated hospitalizations in adult patients with RSV, influenza and SARS-CoV-2
- Estimate the rate of co-infections with other pathogens in adult hospitalized patients with RSV respiratory tract infection
- Determine disease duration and symptoms in adult hospitalized patients with respiratory tract infections caused by RSV, influenza and SARS-CoV-2
- Determine and compare the demographic and clinical characteristics of hospitalized patients with respiratory tract infections
- Determine and compare the clinical course and treatment outcome within a follow-up period of 28 to 90 days in adult hospitalized patients with respiratory tract infections caused by RSV, influenza, SARS-CoV-2
- Record and compare the complications in adult hospitalized patients with respiratory tract infections caused by RSV, influenza, SARS-CoV-2
- Assess the impact of quality of life within a follow-up period of 28 and 90 days in adult hospitalized patients with respiratory infections caused by RSV, influenza, SARS-CoV-2
Exploratory objectives
- Estimate the utility of RT-PCR-based detection of pathogens causing acute respiratory tract infection (ARI) by comparing diagnostic rates of RSV, influenza, and SARS-CoV-2 when tested from nasopharyngeal swabs alone and in addition from saliva specimens in hospitalized patients aged ≥18 years.
- Compare demographic and clinical characteristics of hospitalized ARI patients aged ≥18 years with differential results between nasopharyngeal and saliva specimens with (a) RT-PCR-confirmed RSV, (b) RT-PCR-confirmed influenza virus, and (c) RT-PCR-confirmed SARS-CoV-2.

TIME FRAMEWORK
Three consecutive infection seasons between 2023 and 2026, each from October to April; each observation period of the study patients is planned for up to 90 days.

NUMBER OF PATIENTS
Enrollment of 3,600 adult patients; 3,000 of them aged >50 years

PARTICIPANTS
Patients aged ≥ 18 years hospitalized with symptoms of acute respiratory infection

STUDY SITES
10 university and non-university hospitals

STUDY TYPE/METHODOLOGY
Multicenter, prospective, active surveillance, observational and longitudinal study in an inpatient setting

STUDY DESIGN


PARTICIPATION OF CAPNETZ: IMPLEMENTATION OF AN OWN STUDY PROJECT
The CAPNETZ STIFTUNG has received financial support from GSK company for the BUCOSS-HOSP study. The study is a research project of the CAPNETZ STIFTUNG in accordance with its mission and current medical issues. The CAPNETZ STIFTUNG – from the planning and implementation to the completion of the study, including the evaluation and publication of the study results, will carry out the entire administration of the BUCOSS-HOSP study. Project and data management is also carried out by the CAPNETZ STIFTUNG office and uses the study infrastructure that has been established over the years.
The recruitment of affected patients and data collection are carried out in close cooperation between the CAPNETZ STIFTUNG office and the participating study centers in Germany. In order to analyze the distribution of pathogens in patients with acute respiratory infections, and thus the frequency of RSV infections, virological diagnostics will be carried out centrally at the Institute of Virology at the University Medical Center Freiburg. Prof. Dr. Gernot Rohde, pneumologist at the University Hospital Frankfurt/Main and Chairman of the CAPNETZ STIFTUNG Board of Directors, is responsible for the scientific management of the study. Prof. Dr. Roland Diel, epidemiologist, and Dr. Paul Schmidt, statistician, cooperated closely in the development and evaluation of the study.
The electronic study management system (EDC) for central data collection is developed and maintained by Webspirit Systems GmbH. The long-standing cooperation with Managing Director Torsten Illmann began in 2001 when the CAPNETZ data collection system was developed at the University of Ulm. Webspirit System GmbH works in the field of clinical research and is ISO-9001 certified since 2023.



