B34 J00 J03 J04 J05 J06 J11 J12 J16 J17 J20 J21 J22 J44 H65 H66
Conditions
Interventions
Group 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
Sponsors
CAPNETZ STIFTUNG,Geschäftsstelle an der Medizinischen Hochschule Hannover
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 complications 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. | — |
Countries
Germany
Contacts
Public ContactGrit Barten-Neiner
CAPNETZ STIFTUNG,Geschäftsstelle an der Medizinischen Hochschule Hannover
Outcome results
None listed