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An Assessment of Rapid Streptococcal Tests in Community Clinics in Israel

A Comparison of Available Rapid Streptococcus A Tests in Community Clinics in Israel: Accuracy, Ease of Use and Acceptability.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00535093
Enrollment
7000
Registered
2007-09-26
Start date
2007-10-31
Completion date
2009-07-31
Last updated
2010-05-04

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

Conditions

Pharyngitis, Streptococcus Pyogenes Identification, Streptococcus Pyogenes Infection

Keywords

Pharyngitis, Community infections, Rapid Testing, Group A Streptococcus

Brief summary

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.

Detailed description

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.

Interventions

DEVICErapid streptococcal testing

Each patient will have both RST and standard throat culture performed. Final diagnosis and treatment will be determined by throat culture

Sponsors

Dept of Family Medicine, Faculty of Medicine, Hebrew University, Jerusalem, Israel
CollaboratorOTHER
Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* sore throat * at least two Centor criteria: * fever \> 38 deg C or history of fever * enlarged cervical lymph nodes * tonsillar exudate * lack of cough * age 3-14 years

Exclusion criteria

* antibiotic treatment in preceding 7 days * no informed consent

Design outcomes

Primary

MeasureTime frame
sensitivity of RST specificity of RST3-4 months

Secondary

MeasureTime frame
ease of use effect on antibacterial prescribing3-4 months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026