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

Infectious Diseases Unit
Level 6 Windsor Building
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom

Phone	+44 (0)116 2586952
Email	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

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