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An Assessment of Rapid Streptococcal Tests in Community Clinics in Israel

Primary Purpose

Pharyngitis, Streptococcus Pyogenes Infection, Streptococcus Pyogenes Identification

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
rapid streptococcal testing
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pharyngitis focused on measuring Pharyngitis, Community infections, Rapid Testing, Group A Streptococcus

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clalit Health Services

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

1

Arm Description

All patients fulfilling inclusion criteria will be evaluated for GAS infection using both a rapid streptococcus test and also a standard throat culture

Outcomes

Primary Outcome Measures

sensitivity of RST specificity of RST

Secondary Outcome Measures

ease of use effect on antibacterial prescribing

Full Information

First Posted
September 24, 2007
Last Updated
May 2, 2010
Sponsor
Meir Medical Center
Collaborators
Dept of Family Medicine, Faculty of Medicine, Hebrew University, Jerusalem, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT00535093
Brief Title
An Assessment of Rapid Streptococcal Tests in Community Clinics in Israel
Official Title
A Comparison of Available Rapid Streptococcus A Tests in Community Clinics in Israel: Accuracy, Ease of Use and Acceptability.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Meir Medical Center
Collaborators
Dept of Family Medicine, Faculty of Medicine, Hebrew University, Jerusalem, Israel

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngitis, Streptococcus Pyogenes Infection, Streptococcus Pyogenes Identification
Keywords
Pharyngitis, Community infections, Rapid Testing, Group A Streptococcus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
All patients fulfilling inclusion criteria will be evaluated for GAS infection using both a rapid streptococcus test and also a standard throat culture
Intervention Type
Device
Intervention Name(s)
rapid streptococcal testing
Intervention Description
Each patient will have both RST and standard throat culture performed. Final diagnosis and treatment will be determined by throat culture
Primary Outcome Measure Information:
Title
sensitivity of RST specificity of RST
Time Frame
3-4 months
Secondary Outcome Measure Information:
Title
ease of use effect on antibacterial prescribing
Time Frame
3-4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian N Miskin, MD
Organizational Affiliation
Clalit Health Services, Jerusalem district
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clalit Health Services
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
16567603
Citation
Humair JP, Revaz SA, Bovier P, Stalder H. Management of acute pharyngitis in adults: reliability of rapid streptococcal tests and clinical findings. Arch Intern Med. 2006 Mar 27;166(6):640-4. doi: 10.1001/archinte.166.6.640.
Results Reference
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PubMed Identifier
12394813
Citation
Gieseker KE, Mackenzie T, Roe MH, Todd JK. Comparison of two rapid Streptococcus pyogenes diagnostic tests with a rigorous culture standard. Pediatr Infect Dis J. 2002 Oct;21(10):922-7. doi: 10.1097/00006454-200210000-00007.
Results Reference
background
PubMed Identifier
15069046
Citation
McIsaac WJ, Kellner JD, Aufricht P, Vanjaka A, Low DE. Empirical validation of guidelines for the management of pharyngitis in children and adults. JAMA. 2004 Apr 7;291(13):1587-95. doi: 10.1001/jama.291.13.1587. Erratum In: JAMA. 2005 Dec 7;294(21):2700.
Results Reference
background
PubMed Identifier
12087516
Citation
Bisno AL, Gerber MA, Gwaltney JM Jr, Kaplan EL, Schwartz RH; Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of group A streptococcal pharyngitis. Infectious Diseases Society of America. Clin Infect Dis. 2002 Jul 15;35(2):113-25. doi: 10.1086/340949. No abstract available.
Results Reference
background
PubMed Identifier
16832002
Citation
Linder JA, Chan JC, Bates DW. Evaluation and treatment of pharyngitis in primary care practice: the difference between guidelines is largely academic. Arch Intern Med. 2006 Jul 10;166(13):1374-9. doi: 10.1001/archinte.166.13.1374.
Results Reference
background
PubMed Identifier
11147989
Citation
Ebell MH, Smith MA, Barry HC, Ives K, Carey M. The rational clinical examination. Does this patient have strep throat? JAMA. 2000 Dec 13;284(22):2912-8. doi: 10.1001/jama.284.22.2912.
Results Reference
background
PubMed Identifier
16278359
Citation
Linder JA, Bates DW, Lee GM, Finkelstein JA. Antibiotic treatment of children with sore throat. JAMA. 2005 Nov 9;294(18):2315-22. doi: 10.1001/jama.294.18.2315.
Results Reference
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An Assessment of Rapid Streptococcal Tests in Community Clinics in Israel

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