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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN21521552

Enrollment

2750

Registered

2005-03-30

Start date

2005-11-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, respiratory syncytial virus (RSV) and Streptococcus pneumoniae Infections and Infestations

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
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.	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026