Acute respiratory infections Respiratory Acute respiratory infections
Conditions
Interventions
This is an observational study. Blood and respiratory samples will be collected at baseline, day 2, date of hospital discharge (if applicable) and day 28. Samples will be analysed to determine aetiolo
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: Group 1 – primary care patients: 1. Age = 18 years 2. Patient is self-attending to primary care (i.e. ambulatory) 3. Clinical suspicion of a new episode of acute respiratory tract infection 4. Onset of the following symptoms within the last 7 days: 4.1. Sudden onset of self-reported fever OR tympanic temperature of = 38°C at presentation AND 4.2. At least one respiratory symptom (cough, sore throat, runny or congested nose) AND 4.3. At least one systemic symptom (headache, muscle ache, sweats or chills or tiredness) Group 2 – hospitalised patients: 1. Age = 18 years 2. Clinical suspicion of a new episode of acute respiratory tract infection 3. Patient is admitted to hospital 4. Primary reason for hospital admission is clinical suspicion of a new episode of ARI 5. Onset of the following symptoms within the last 7 days: 5.1. Sudden onset of self-reported fever OR tympanic temperature of = 38°C at presentation AND 5.2. At least one respiratory symptom (cough, sore throat, runny or congested nose) AND 5.3. At least one systemic symptom (headache, muscle ache, sweats or chills or tiredness)
Exclusion criteria
Exclusion criteria: Group 1 – primary care patients: 1. Patient lacks capacity to provide informed consent 2. No informed consent is provided by patient 3. The attending primary care physician decided to send patient to the hospital for assessment and possible hospital admission 4. Patient is enrolled in an interventional clinical study Group 2 – hospitalised patients: 1. Patient lacks capacity to provide informed consent 2. No informed consent is provided by patient 3. Patient has been transferred from another hospital 4. Patient is enrolled in an interventional clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differentially expressed host genes (nominal = 2-fold difference in expression levels) as assessed by RNA transcriptome microarray in hospitalised and primary care managed cases of ARI, stratified by pathogen* and comorbidity**. *Influenza virus, Human Rhinovirus, Respiratory Syncytial Virus, Streptococcus pneumoniae **No comorbidity, chronic pulmonary disease, chronic cardiovascular disease, chronic metabolic disease (diabetes) | — |
Secondary
| Measure | Time frame |
|---|---|
| In both groups: 1. Prevalence of detection of putative pathogens in respiratory tract samples 2. Proportion of cases receiving antibiotics, antivirals, antifungals and/or immunomodulators. 3. 28-day mortality Additional in group 1 (primary care): 1. Proportion of cases requiring hospitalisation Additional in group 2 (hospitalised patients): 1. Severity of illness at enrolment as assessed by Pneumonia Severity Index (PSI) and CURB-65 2. Proportion of cases requiring during admission: supplemental oxygen; non-invasive or invasive mechanical ventilation; extra-corporeal life support 3. Duration of invasive mechanical ventilation and extra-corporeal life support, if applicable 4. Proportion of cases requiring Intensive Care Unit (ICU)/High Care Unit (HCU) admission 5. Hospital and ICU/HCU length of stay 6. In-hospital mortality | — |
Countries
Croatia, England, Germany, Ireland, Netherlands, Poland, Romania, Spain, United Kingdom
Contacts
Public ContactStudy Team
Outcome results
None listed