Randomised controlled trial to evaluate impact of diagnostic testing for influenza, respiratory syncytial virus, Streptococcus pneumoniae infection on the management of acute admissions in the elderly and high-risk 18-64 year old
| ISRCTN | ISRCTN21521552 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21521552 |
| Protocol serial number | HTA 03/39/18 |
| Sponsor | University Hospitals of Leicester NHS Trust (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 24/03/2005
- Registration date
- 30/03/2005
- Last edited
- 02/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Karl Nicholson
Scientific
Scientific
Infectious Diseases Unit
Level 6 Windsor Building
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
| Phone | +44 (0)116 2586952 |
|---|---|
| karlgnicholson@doctors.org.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | This is a prospective, randomised controlled trial that evaluates the impact of rapid diagnostic testing for influenza, respiratory syncytial virus and streptococcus pneumoniae, on the management and outcome of acute cardio-pulmonary admissions in the elderly (age >65 years), and 'high risk' individuals with underlying chronic heart or lung disease, including asthma, who are >18 years of age. The cost effectiveness of near patient and rapid molecular tests will also be assessed. Please note that, as of 11/05/2009, the anticipated end date has been updated from 31/10/2008 to 30/04/2009. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Influenza, respiratory syncytial virus (RSV) and Streptococcus pneumoniae |
| Intervention | Patients in each centre will be randomly allocated to one of three diagnostic groups: Group 1: Near patient tests (Quidel-influenza; Binax NOW-pneumococcus) Group 2: Rapid molecular tests (influenza and RSV) plus laboratory testing of concentrated urine in the Binax NOW assay Group 3: Traditional laboratory culture |
| Intervention type | Other |
| Primary outcome measure(s) | Our remit from the NHS HTA is to determine the diagnostic accuracy and clinical and cost effectiveness of rapid molecular and near patient test for influenza, RSV, and S pneumoniae, in comparison to traditional laboratory culture. There are a number of outcome measures: The impact of test results on prescribing, clinical outcomes (length of stay, ITU admissions, ventilatory support, deaths), quality of life and use of isolation facilities. |
| Key secondary outcome measure(s) | Financial outcome measures: Total costs of diagnostic tests, total care costs, cost savings and effectiveness (cost per case detected and cost per QUALY). Laboratory outcome measures: Diagnostic accuracy (sensitivity, specificity, positive and negative predictive values, ease of tests and speed of tests. Observational outcomes: Estimated admission rates for influenza, RSV and S pneumoniae. |
| Completion date | 30/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 2750 |
| Key inclusion criteria | 1. Age >65 years or age >18 years with underlying chronic heart or lung disease including asthma 2. Have an acute exacerbation of chronic cardio-pulmonary illness of <120 hours (5 days) duration or an acute cardio-pulmonary illness or influenza-like illness of <5 days duration, including: pneumonia, influenza/influenza-like illness, exacerbations of chronic obstructive pulmonary disease (COPD), bronchitis, asthma, congestive heart failure, cardiac arrhythmia |
| Key exclusion criteria | 1. Inclusion criteria not met 2. Angina 3. Suspected myocardial infarction 4. Dementia 5. Psychotic disorder 6. Cardio-pulmonary illness that is so severe that the patient can not provide written informed consent |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 30/04/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Infectious Diseases Unit
Leicester
LE1 5WW
United Kingdom
LE1 5WW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2014 | Yes | No |
