PRImary care Streptococcal Management study (PRISM) Rapid tests for streptococcal sore throat

ISRCTN	ISRCTN32027234
DOI	https://doi.org/10.1186/ISRCTN32027234
Secondary identifying numbers	HTA 05/10/01

Submission date: 13/02/2007
Registration date: 27/02/2007
Last edited: 31/01/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Study website

Contact information

Prof Paul Little
Scientific

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Phone	+44 (0)23 80241062
Email	psl3@soton.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Not specified
Study type	Diagnostic
Participant information sheet	Find information pertinent to closest recruitment site at: http://www.prismstudy.org/Study_Documents/default.htm
Scientific title
Study acronym	PRISM
Study hypothesis	1. To assess which Rapid streptococcal antigen detection test (RADT) is the most accurate in predicting the presence of group A streptococcus by throat swab in a clinical sample from primary care 2. To estimate the error from sampling bias by performing parallel standardised in vitro studies 3. To assess the validity of a scoring system based on the throat swab as the reference standard (such as the Centor criteria) in a UK population 4. To assess the effectiveness and cost-effectiveness of rapid tests when compared to clinical scoring rules and delayed antibiotic prescription 5. To explore the effect of additional benefit from the RADT use on GP diagnostic prediction accuracy and treatment decisions
Ethics approval(s)	Southampton and South West hampshire REC, MREC number: 06/Q1702/111
Condition	Lower Respiratory Tract Infections (LRTI)
Intervention	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 settings of the 5 currently available RADTs using the throat swab as the reference standard 2. Nested data from the same sample will be used to assess whether the a scoring system based on the throat swab as a reference standard (such as the Centor criteria) requires modification 3. In vitro studies to assess the performance of RADTs in standardised conditions and thus assess the issue of sampling bias when using RADTs 4. A qualitative study to explore patients and GPs perceptions about the use of RADTs Phase II. This trial will compare management using a) the best RADT defined from phase 1 compared with b) a clinical scoring rule (a Centor-like criteria based on predicting the results of throat swabs) and c) with the empirical strategy of delayed antibiotic prescription. Phase II will include a cost consequences analysis, which along with a review of the longer term effects of reduced antibiotic resistance will feed into a simple cost effectiveness model. Phase I. RADTs: in adults two double throat swabs will be taken (allowing four tests for each adult), and in children only one double swab (due to multiple swabs being less acceptable in children). Each swab will be used for both conventional microbiology (culture and sensitivity) and for one of five randomly chosen rapid tests (piloting has shown this is feasible and minimises sampling variation). We will assess currently available RADTs (Streptatest; OSOM Ultra Strep A; Quickvue; 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 RADT for phase II will take account of the best clinical study results, the in vitro results, and ease of use. Phase II. Patients will be individually randomised using a web based service to three groups, stratified by physician belief in the likelihood of bacterial infection: 1 ) RADT use 2) Clinical scoring rule 3) Delayed prescribing. The RADT used, and the optimal strategy for use, will be identified from Phase I. The clinical score will be the Centor criteria (3 out of 4 criteria present), or the alternative clinical rule developed from phase I . Delayed prescribing will involve antibiotics to be used/collected after 3-5 days if symptoms are worsening or not starting to settle.
Intervention type	Other
Primary outcome measure	Phase 1: Ease of use and performance in clinical setting of 5 RADTs Phase 2: Diary scores; duration of illness
Secondary outcome measures	Phase 2: 1. Antibiotic use 2. Side effects 3. Medicalistion of illness
Overall study start date	01/10/2006
Overall study end date	30/09/2010

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	Phase 1: 438 -1176; Phase 2: 850
Participant 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.
Participant 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).
Recruitment start date	01/10/2006
Recruitment end date	30/09/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Primary Medical Care

Southampton
SO16 5ST
United Kingdom

Sponsor information

University of Southampton (UK)
University/education

(c/o Dr Martina Dorward)
Research Support Office
Building 37, Room 4009
University of Southampton
Highfield
Southampton
SO17 1BJ
England
United Kingdom

Phone	+44 (0)23 80598848
Email	mad4@soton.ac.uk
"ROR"	https://ror.org/01ryk1543

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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	10/10/2013		Yes	No
Results article	results	01/01/2014		Yes	No