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An Assessment of Rapid Streptococcal Tests in Community Clinics in Israel

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ClinicalTrials.gov Identifier: NCT00535093
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : May 4, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Pharyngitis Streptococcus Pyogenes Infection Streptococcus Pyogenes Identification Device: rapid streptococcal testing

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Comparison of Available Rapid Streptococcus A Tests in Community Clinics in Israel: Accuracy, Ease of Use and Acceptability.
Study Start Date : October 2007
Primary Completion Date : July 2009
Study Completion Date : July 2009
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. sensitivity of RST specificity of RST [ Time Frame: 3-4 months ]

Secondary Outcome Measures :
  1. ease of use effect on antibacterial prescribing [ Time Frame: 3-4 months ]

Eligibility Criteria

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535093


Locations
Israel
Clalit Health Services
Jerusalem, Israel
Sponsors and Collaborators
Meir Medical Center
Dept of Family Medicine, Faculty of Medicine, Hebrew University, Jerusalem, Israel
Investigators
Principal Investigator: Ian N Miskin, MD Clalit Health Services, Jerusalem district
More Information

Publications:
Responsible Party: Ian MiskinMD, Clalit Health Services Jerusalem Israel
ClinicalTrials.gov Identifier: NCT00535093     History of Changes
Other Study ID Numbers: HT4152
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: May 4, 2010
Last Verified: September 2009

Keywords provided by Meir Medical Center:
Pharyngitis
Community infections
Rapid Testing
Group A Streptococcus

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases