BUrden of Disease and COst of illneSS for RSV and other pathogens in patients 60 years and older within the outpatient setting
- Conditions
- J20J21J22J44H65H66B34J00J03J04
- Registration Number
- DRKS00030320
- Lead Sponsor
- CAPNETZ STIFTUNG,Geschäftsstelle an der Medizinischen Hochschule Hannover
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3000
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:
- 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To describe the prevalence of RT-PCRconfirmed<br>RSV among adults =60 years of<br>age presenting with ARI in the out-patient<br>setting in Germany.<br><br>2. To describe co-infections with other<br>respiratory pathogens (section 10.3) among<br>RT-PCR-confirmed RSV-positive ARI patients<br>=60 years of age in the primary care setting<br>in Germany.
- Secondary Outcome Measures
Name Time Method