An Assessment of Rapid Streptococcal Tests in Community Clinics in Israel

May 2, 2010 updated by: Meir Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

7000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Clalit Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
All patients fulfilling inclusion criteria will be evaluated for GAS infection using both a rapid streptococcus test and also a standard throat culture
Device: rapid streptococcal testing
Each patient will have both RST and standard throat culture performed. Final diagnosis and treatment will be determined by throat culture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sensitivity of RST specificity of RST
Time Frame: 3-4 months
3-4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
ease of use effect on antibacterial prescribing
Time Frame: 3-4 months
3-4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Collaborators

Dept of Family Medicine, Faculty of Medicine, Hebrew University, Jerusalem, Israel

Investigators

  • Principal Investigator: Ian N Miskin, MD, Clalit Health Services, Jerusalem district

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

September 24, 2007

First Submitted That Met QC Criteria

September 25, 2007

First Posted (Estimate)

September 26, 2007

Study Record Updates

Last Update Posted (Estimate)

May 4, 2010

Last Update Submitted That Met QC Criteria

May 2, 2010

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HT4152

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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