Pharyngitis Clinical Trial
Official title:
A Comparison of Available Rapid Streptococcus A Tests in Community Clinics in Israel: Accuracy, Ease of Use and Acceptability.
There is a large over-use of antibiotics in family medicine, especially in upper respiratory
tract infections.
This study is designed to determine if the use of rapid Streptococcal tests in primary care
clinics can lower the rate of antibiotic use while not missing bacterial infections.
Pharyngitis is a clinical diagnosis which requires antibiotic treatment only if caused by
group A Streptococcus (GAS).
However, it is impossible to identify by clinical signs alone those patients whose symptoms
are caused by this pathogen.
Diagnosis demands a throat culture, which requires at least 24 hours to rule in infection
and 48 hours to rule it out.
Rapid Streptococcal tests (RST) based on antigen identification have been in use for over 10
years. These allow determination of the presence of GAS within 10 minutes using tests
designed for point of care use.
While the specificity of these tests is generally reported as high (90-95%), the sensitivity
is quoted at between 60% and 90% , depending on author affiliation, place of testing and
type of test.
Various protocols have been put forward, these combine clinical signs (Centor criteria) with
RST or throat cultures in order to lower antibiotic over-use.
These protocols are often under-used by primary physicians, even when RSTs are available.
Clalit health services, the largest HMO in Israel, has decided to evaluate all the RSTs
available in the country in community clinic settings in order to determine the feasibility
of adopting these tests to improve clinical care.
The sensitivity, specificity and ease-of-use will be assessed in 25 clinics in various
settings (urban and rural). Gold standard will be a standard throat culture processed in the
district laboratory.
The effect of point-of-care testing will be estimated by requiring physicians to decide on
antibiotic use before receiving the result of the RST. (They will be free to change this
decision after the test).
Clinics were selected by number of throat cultures sent in previous years. The number of
patients was determined using the positivity rates of 2005. The results of this study will
enable us to estimate the benefit and cost of adopting RSTs, and to determine in which
situations they will be most efficacious.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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