Lower Respiratory Tract Infections (LRTI) Respiratory Lower Respiratory Tract Infections
Conditions
Interventions
This study is in two phases:
Phase I is a validation and development phase and will include five components:
1. A clinical study to determine the ease of use and overall performance in clinical sett
OSOM Ultra Strep A
Clearview Exact Test
and IMI Test Pack plus Strep A). Variation in performance due to sampling bias will be assessed by in vitro studies, using standard antigen loads of three group A streps and controls. The choice of RA
Sponsors
University of Southampton (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Phase 1: Adults/children aged 5 and over presenting with acute sore throat ( 2 weeks or less; and with some abnormality of examination of the throat ? i.e. erythema and/or pus). Phase 2: . Previously well subjects aged 3 years and over with acute illness (2 weeks or less), presenting with sore throat as the main symptom, with an abnormal examination of the pharynx.
Exclusion criteria
Exclusion criteria: Phase 1: 1. Other non infective causes of sore throat (e.g. apthous ulceration, candida, drugs) 2. Unable to consent (e.g. dementia, uncontrolled psychosis) Phase 2: 1. Quinsy, previous rheumatic fever, glomerulonephritis. 2. Serious chronic disorders where antibiotics are needed (e.g. cystic fibrosis, valvular heart disease), or mental health problems (e.g. learning difficulties - unable to complete outcome measures).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: Ease of use and performance in clinical setting of 5 RADTs Phase 2: Diary scores; duration of illness | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 2: 1. Antibiotic use 2. Side effects 3. Medicalistion of illness | — |
Countries
United Kingdom
Outcome results
None listed