PharyngitisNCT00535093
An Assessment of Rapid Streptococcal Tests in Community Clinics in Israel
A study testing rapid streptococcal testing in people with Pharyngitis and Streptococcus Pyogenes Infection, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Pharyngitis, Streptococcus Pyogenes Infection, Streptococcus Pyogenes Identification
- What is being tested?
- rapid streptococcal testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,000 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2007to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- antibiotic treatment in preceding 7 days
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- rapid streptococcal testing
- Keywords
- Pharyngitis, Community infections, Rapid Testing, Group A Streptococcus
- Medical subject headings
- Pharyngitis, Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapid streptococcal testingDevice
Each patient will have both RST and standard throat culture performed. Final diagnosis and treatment will be determined by throat culture
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | All patients fulfilling inclusion criteria will be evaluated for GAS infection using both a rapid streptococcus test and also a standard throat culture Receives: Device: rapid streptococcal testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity of RST specificity of RST
Measured: 3-4 months
Secondary outcomes (1)
ease of use effect on antibacterial prescribing
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PharyngitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dept of Family Medicine, Faculty of Medicine, Hebrew University, Jerusalem, Israel
- Investigators
- Ian N Miskin, MD, Principal investigator, Clalit Health Services, Jerusalem district
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535093
- Sponsor's protocol ID
- HT4152
- Status last verified
- Sep 2009
- First submitted
- 24 Sep 2007
- Last updated
- 4 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16567603Gieseker 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.
PubMed 12394813McIsaac 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.
PubMed 15069046Bisno 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.
PubMed 12087516Linder 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.
PubMed 16832002Ebell 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.
PubMed 11147989Linder 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.
PubMed 16278359
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Available Rapid Streptococcus A Tests in Community Clinics in Israel: Accuracy, Ease of Use and Acceptability.
- ClinicalTrials.gov ID
- NCT00535093
- Acronym / sponsor ID
- HT4152
- Keywords
- Pharyngitis, Community infections, Rapid Testing, Group A Streptococcus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Dept of Family Medicine, Faculty of Medicine, Hebrew University, Jerusalem, Israel
- Study start
- Oct 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | Device: rapid streptococcal testingAll patients fulfilling inclusion criteria will be evaluated for GAS infection using both a rapid streptococcus test and also a standard throat culture |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- sore throat
- at least two Centor criteria:
- fever > 38 deg C or history of fever
- enlarged cervical lymph nodes
- tonsillar exudate
Key exclusion criteria (2 listed)
- antibiotic treatment in preceding 7 days
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rapid streptococcal testingEach patient will have both RST and standard throat culture performed. Final diagnosis and treatment will be determined by throat culture | Device | 1 |
Primary outcome
sensitivity of RST specificity of RST
Time frame: 3-4 months
1 secondary outcome
ease of use effect on antibacterial prescribing
Time frame: 3-4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2010.
- Background: PubMed 16567603Humair 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.
- Background: PubMed 12394813Gieseker 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.
- Background: PubMed 15069046McIsaac 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.
- Background: PubMed 12087516Bisno 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.
- Background: PubMed 16832002Linder 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.
- Background: PubMed 11147989Ebell 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.
- Background: PubMed 16278359Linder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian N Miskin, MD principal investigator
Clalit Health Services, Jerusalem district
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rapid streptococcal testing in people with Pharyngitis and Streptococcus Pyogenes Infection, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of RST specificity of RST (time frame: 3-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00535093, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2010.