Vaccine-preventable acute lower respiratory tract infections Respiratory Unspecified acute lower respiratory infection
Conditions
Interventions
AvonCAP GP2 is a prospective cohort study that aims to estimate the incidence and burden of acute lower respiratory tract infection (aLRTI) in adults presenting to primary care in Bristol, including v
and an embedded diagnostic study, collecting additional data, including an enrolment survey (including quality of life), symptom diary (including symptoms, time off work and quality of life) and naso-
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged =18 years of age; AND 2. Presenting to primary care with acute illness (i.e., present for 28 days or less); AND 3. Evidence of aLRTD* as guided by the following criteria: 3.1. Evidence of aLRTI (including acute bronchitis, pneumonia and infective exacerbations of chronic lung disease): 3.1.1. Clinical suspicion of LRTI and new/worsened cough with one or more of the following signs/symptoms: sputum production or purulence, chest pain, wheeze, shortness of breath, tachypnoea or abnormal auscultatory findings suggestive of aLRTI; OR 3.1.2. Clinical diagnosis of aLRTI OR 3.2. Evidence of acute exacerbation of pre-existing heart failure with respiratory symptoms: 3.2.1. Clinical suspicion of acute exacerbation of pre-existing heart failure and new or worsening of two or more of the following signs/symptoms: cough (including nocturnal cough), shortness of breath, wheeze, tachypnoea, abnormal auscultatory findings suggestive of exacerbation of heart failure; OR 3.2.2. Clinical diagnosis of acute exacerbation of heart failure with respiratory symptoms OR 3.3. Evidence of non-infective exacerbation of pre-existing chronic lung disease: 3.3.1. Clinical suspicion of presumed non-infective exacerbation of pre-existing chronic lung disease and new or worsening of two or more of cough, shortness of breath, wheeze, tachypnea, abnormal auscultatory findings suggestive of acute non-infective exacerbation; OR 3.3.2. Clinical diagnosis of non-infective exacerbation *Acute lower respiratory tract disease (aLRTD) includes acute lower respiratory tract infection (aLRTI) and its subgroups, acute exacerbation of pre-existing heart failure and presumed non-infective exacerbation of chronic lung disease.
Exclusion criteria
Exclusion criteria: 1. Previously enrolled participants within 28 days of the onset of the study qualifying aLRTD illness 2. At the time of enrolment, alternative non-LRTD working diagnosis suspected 3. Presenting to primary care with the same episode of aLRTD for which they have been discharged from hospital 4. Any patient who develops signs and symptoms of LRTD after being hospitalized for =48 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of acute lower respiratory tract infection (aLRTI) in adults presenting to primary care and the proportion caused by vaccine preventable infections, including Streptococcus pneumoniae, Respiratory Syncytial Virus (RSV) and SARS-CoV-2. Measured using data extracted from primary care medical records and samples collected over a 30-month period between February 2022 and July 2024. | — |
Secondary
| Measure | Time frame |
|---|---|
| Collected over a 30-month period between February 2022 and July 2024: 1. The demographic (e.g. age, sex, deprivation), clinical (e.g. symptoms, signs, severity, comorbidities), and microbiological (all respiratory pathogens) characteristics for adults presenting to primary care with aLRTD, overall and by final clinical diagnosis. Demographic and clinical data will be measured at baseline and Day 30 (for a subset of patients) using data extracted from primary care medical records. Microbiological characteristics will be assessed through sampling data collected through the enhanced diagnostic study arm. 2. The natural history of aLRTD, including patient-reported symptom duration and severity; antibiotic/antiviral consumption; respiratory pathogen isolation; time off work, primary care consultations, hospital admission and quality of life (EQ-5D) initially for up to 28 days after presentation to primary care (and up to a maximum of 12 months for those who have not recovered at 28 days), overall and by final clinical diagnosis. This will be measured using data extracted from primary care medical records, symptom diaries and sampling data. 3. Time trends in population-based incidence rates of aLRTD related to fluctuations in the COVID-19 pandemic. This will be measured using data extracted from primary care medical records at baseline, counting patients presenting to primary care with aLRTD, and sampling data. 4. Mortality rate at 30 days (and up to a maximum of 12 months for those who have not recovered at 28 days) after primary care visit for aLRTD (and its subcategories), overall and by age group and risk group status. Mortality rates will be measured through data extracted from primary care medical records. 5. The pathogen distribution rates of RSV, SARS-CoV-2, and other viral pathogens among adults diagnosed with exacerbation of congestive heart failure, non-infective exacerbation of asthma and non-infective exacerbation of COPD. This will be measured through | — |
Countries
England, United Kingdom
Outcome results
None listed