Clinical Trials Logo

Clinical 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.


Clinical Trial 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT00535093
Study type Interventional
Source Meir Medical Center
Contact
Status Completed
Phase N/A
Start date October 2007
Completion date July 2009

See also
  Status Clinical Trial Phase
Completed NCT01453400 - Evaluate the Time of Pain Relief of Fast Acting Aspirin Versus Acetaminophen in Subjects Diagnosed With Sore Throat Pain Phase 3
Completed NCT04016051 - Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections Phase 3
Recruiting NCT01681667 - Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain Phase 4
Completed NCT00527852 - Assessment of Flocked Swabs for the Identification of Group A Streptococcal Pharyngitis N/A
Completed NCT02178293 - Ketoprofen Lysine Salt as Mouthwash in Acute Phlogosis of the Pharyngeal Cavity Versus Benzidamine Hydrochloride Phase 4
Active, not recruiting NCT05127161 - Broad Implementation of Outpatient Stewardship N/A
Withdrawn NCT02535962 - Probiotics and Corticosteroids for Treating Periodic Fever, Aphthous Stomatitis, Pharyngitis, Cervical Adenitis (PFAPA) Phase 2
Not yet recruiting NCT02252419 - Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat N/A
Completed NCT00798018 - Effect of Intra-cuff Lidocaine and Tetracaine on Tracheal Tube-induced Emergence Phenomena N/A
Completed NCT00148499 - Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis Phase 3
Completed NCT00095368 - APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat Phase 3
Recruiting NCT06027593 - Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions N/A
Recruiting NCT03720301 - The Use of Osteopathic Medical Manipulation to Decrease the Incidence and Severity of Post-Operative Sore Throat N/A
Completed NCT01361399 - Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold Phase 3
Completed NCT01398696 - Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour Phase 4
Completed NCT01048866 - A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis Phase 3
Completed NCT01049334 - A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis Phase 3
Completed NCT00547391 - Recurrent Throat Infections and Tonsillectomy Phase 4
Completed NCT00242281 - APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat Phase 3
Completed NCT01465009 - Placebo and Active Controlled Study to Compare the Efficacy of Aspirin and Paracetamol in Treatment of Sore Throat Associated With a Common Cold Phase 4