BUrden of Disease and COst of illneSS for RSV and other pathogens in patients 60 years and older within the outpatient setting
Organizational Data
- DRKS-ID:
- DRKS00030320
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2022-10-17
- Last update in DRKS:
- 2023-07-21
- Registration type:
- Prospective
Acronym/abbreviation of the study
BUCOSS RSV 60+
URL of the study
No Entry
Brief summary in lay language
The aim of the study is a survey of pathogen diversity and the course of the disease in adults (age >= 60 years) with respiratory infections in selected general practitioners and specialist practices in Germany. The costs of the illness should also be determined. In addition to the main pathogen RSV, the frequency of other pathogens such as flu viruses or the SARS CoV2 virus should also be shown.
Brief summary in scientific language
The aim of this study is prospective surveillance of ARI in out-patients attributable to RSV including the impact of comorbidities, resulting complications, economic and quality of life (QoL) impact on out-patients. Additionally, co-circulating viral pathogens causing ARI will be analyzed. It is well known that patients aged ≥60 having comorbidities are particularly at risk for a severe course of disease in the event of a viral infection. However,there is insufficient evidence about which pathogens cause these infections frequently. This project comprehensively and structurally records the circulating pathogens in the focused age group in the framework of respiratory tract infections and should therefore make an important contribution to clarifying the existing ambiguities.
Health condition or problem studied
- ICD10:
- B34 - Viral infection of unspecified site
- ICD10:
- J00 - Acute nasopharyngitis [common cold]
- ICD10:
- J03 - Acute tonsillitis
- ICD10:
- J04 - Acute laryngitis and tracheitis
- ICD10:
- J05 - Acute obstructive laryngitis [croup] and epiglottitis
- ICD10:
- J06 - Acute upper respiratory infections of multiple and unspecified sites
- ICD10:
- J11 - Influenza, virus not identified
- ICD10:
- J12 - Viral pneumonia, not elsewhere classified
- ICD10:
- J16 - Pneumonia due to other infectious organisms, not elsewhere classified
- ICD10:
- J17 - Pneumonia in diseases classified elsewhere
- ICD10:
- J20 - Acute bronchitis
- ICD10:
- J21 - Acute bronchiolitis
- ICD10:
- J22 - Unspecified acute lower respiratory infection
- ICD10:
- J44 - Other chronic obstructive pulmonary disease
- ICD10:
- H65 - Nonsuppurative otitis media
- ICD10:
- H66 - Suppurative and unspecified otitis media
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Study sites screen patients based on inclusion and exclusion criteria and are expected to include 1 eligible and willing patient per day into the study. At Day 0 demographic and medical data are collected by the study site. The patient delivers data about quality of life, indirect costs and employment status during the visit. All data are documented in the central and web-based database. A nasopharyngeal swab is collected at Day 0 and sent to the central virology department at Freiburg by Over-Night- Delivery. Here, the pathogen is identified using a viral multiplex panel. The result is reported to the study site and documented in the database. Participants with a positive RSV test result are followed up by telephone at Day 14 and, if the patient is not fully recovered, again at Day 28. Data on ongoing symptoms, HCRU, complications, HRQoL and costs are collected during follow-up. Information about Hospitalization during the time of study participation is collected as soon as the information is available. Study sites transmit a full weekly screening record of all visits of patient aged ≥ 60 years and all visits of patients aged ≥ 60 years with ARI-related ICD-10 codes.
Endpoints
- Primary outcome:
- 1. To describe the prevalence of RT-PCRconfirmed RSV among adults ≥60 years of age presenting with ARI in the out-patient setting in Germany. 2. To describe co-infections with other respiratory pathogens (section 10.3) among RT-PCR-confirmed RSV-positive ARI patients ≥60 years of age in the primary care setting in Germany.
- Secondary outcome:
- 1. To estimate the incidence of RSV among adults ≥60 years of age presenting with ARI in the primary care setting in Germany. 2. To describe the duration of illness and type of ARI symptoms/signs in RT-PCR-confirmed RSV-positive ARI patients ≥60 years of age in the primary care setting in Germany. 3. To describe complications2 among RT-PCRconfirmed RSV-positive ARI patients ≥60 years of age presenting in the primary care setting in Germany. 4. To describe the proportion of patients hospitalized within 28 days of RT-PCRconfirmed RSV-positive ARI diagnosed in the primary care setting in Germany. 5. To describe health care resource utilization and economic burden associated with RTPCR- confirmed RSV-positive ARI diagnosed in the primary care setting in Germany. 6. To describe the impact on health-related quality of life (HRQoL) in RT-PCR-confirmed RSV-positive ARI patients ≥60 years of age presenting in the primary care setting in Germany. 7. To describe the demographic and clinical characteristics of patients, including comorbidities, for both RT-PCR-confirmed RSV-positive ARI cases and RT-PCRconfirmed RSV-negative ARI cases in the primary care setting in Germany. 8. To describe the prevalence of ARI attributable to respiratory pathogens other than RSV in patients ≥60 years of age in the primary care setting in Germany, by pathogen.
Study Design
- Purpose:
- Diagnostic
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Doctor's practice Rotenburg/Wümme
- Doctor's practice Neuenkirchen
- Doctor's practice Berlin
- Doctor's practice Bad Dürkheim
- Doctor's practice Bochum
- Doctor's practice Reutlingen
- Doctor's practice Bühl
- Doctor's practice Goch
- Doctor's practice Köln
Recruitment period and number of participants
- Planned study start date:
- 2022-10-17
- Actual study start date:
- 2022-11-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 3000
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 60 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Eligibility criteria Inclusion Criteria: General inclusion criteria - Willingness to participate (signed informed consent) - Age 60+ - onset date of the first ARI symptom/sign must be within the 7 days prior to Day 0/Visit 1 Further inclusion criteria (ARI symptoms), at least two respiratory OR at least 1 respiratory AND 1 systemic symptom/sign have to be present: Respiratory symptoms/signs - Cough - Purulent sputum or change in the sputum texture - Sore throat - Runny nose/nasal congestion - Rales/Wheezing - Acute or progressive dyspnea/tachypnea (MRC dyspnea scale above 0) Acute or progressive hypoxemia (O2 saturation below 95%) Systemic Symptoms/Signs - Body aches - Feverishness or chills - Fatigue
Exclusion Criteria
Exclusion Criteria: - No ability to follow study procedures - History of vaccination with an investigational RSV vaccine - Participation in an investigational study/clinical trial - Enrolled in the study within the previous 28 days
Addresses
Primary Sponsor
- Address:
- CAPNETZ STIFTUNG,Geschäftsstelle an der Medizinischen Hochschule HannoverGrit Barten-NeinerCarl-Neuberg-Straße 130625 HannoverGermany
- Telephone:
- +49 (0)511 532 4434
- Fax:
- +49 (0)511 532 8286
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.capnetz.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- CAPNETZ STIFTUNG,Geschäftsstelle an der Medizinischen Hochschule HannoverGrit Barten-NeinerCarl-Neuberg-Straße 130625 HannoverGermany
- Telephone:
- +49 (0)511 532 4434
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.capnetz.de
Contact for Public Queries
- Address:
- CAPNETZ STIFTUNG,Geschäftsstelle an der Medizinischen Hochschule HannoverGrit Barten-NeinerCarl-Neuberg-Straße 130625 HannoverGermany
- Telephone:
- +49 (0)511 532 4434
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.capnetz.de
Principal Investigator
- Address:
- CAPNETZ STIFTUNG,Geschäftsstelle an der Medizinischen Hochschule HannoverGrit Barten-NeinerCarl-Neuberg-Straße 130625 HannoverGermany
- Telephone:
- +49 (0)511 532 4434
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.capnetz.de
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- GlaxoSmithKline Biologicals SA1330 RixensartBelgium
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission des Fachbereichs Medizin Universitätsklinikum der Goethe-Universität c/o UniversitätsklinikumTheodor-Stern-Kai 7, Haus 1, 2. OG, Zimmer 207-21160590 Frankfurt/MainGermany
- Telephone:
- +49-69-63017239
- Fax:
- +49-69-630183434
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-08-25
- Ethics committee number:
- 2022-907
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-10-14
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- Scientists for research projects in the context of respiratory infections can have limited access to the medical data stored in the central database. In addition, anonymous data (= medical data without a pseudonym) can be used for evaluations by scientists outside of the BUCOSS RSV 60+ study if this has been checked and approved by the board of the CAPNETZ FOUNDATION. When study results are published, the data will not reveal who participated in the study.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry