Condition category
Infections and Infestations
Date applied
24/03/2005
Date assigned
30/03/2005
Last edited
02/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Karl Nicholson

ORCID ID

Contact details

Infectious Diseases Unit
Level 6 Windsor Building
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
+44 (0)116 2586952
karlgnicholson@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 03/39/18

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 outcome measures

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.

Overall trial start date

01/11/2005

Overall trial end date

30/04/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

2750

Participant 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

Recruitment start date

01/11/2005

Recruitment end date

30/04/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Infectious Diseases Unit
Leicester
LE1 5WW
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom

Sponsor type

University/education

Website

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24875092

Publication citations

  1. Results

    Nicholson KG, Abrams KR, Batham S, Medina MJ, Warren FC, Barer M, Bermingham A, Clark TW, Latimer N, Fraser M, Perera N, Rajakumar K, Zambon M, Randomised controlled trial and health economic evaluation of the impact of diagnostic testing for influenza, respiratory syncytial virus and Streptococcus pneumoniae infection on the management of acute admissions in the elderly and high-risk 18- to 64-year-olds., Health Technol Assess, 2014, 18, 36, 1-274, vii-viii, doi: 10.3310/hta18360.

Additional files

Editorial Notes