- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03137823
Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface
Diagnosis of Group A beta hemolytic strep tonsillitis -
- cultre of tonsills (gold standard)
- culture from bucal surface (test)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will examine 2 groups. first group of 50 children aged 3-18 years and the second group of adults aged 18-65 with a clinical diagnosis of tonsillitis and centor criteria of 2 or more (fever, exudates on tonsills, no cough, enlarged lymph nodes).
In each patient we'll take 2 cultures - the first from the tonsills and the second from the bucal surface. both of them will be sent to MEGA-LAB .
the treatment will be based only on the gold standrad culture from the tonsills.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: LIMOR ADLER, MD
- Phone Number: +972-524206797
- Email: adler_l@mac.org.il
Study Contact Backup
- Name: MICHAL YANAI
- Phone Number: +972-7958602
- Email: yanai_m@mac.org.il
Study Locations
-
-
-
Ofakim, Israel
- Recruiting
- Maccabi
-
Contact:
- LIMOR ADLER, MD
- Phone Number: +972524206797
- Email: adler_l@mac.org.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- tonsills exudates
- Centor criteria - 2 or more
Exclusion Criteria:
- tonsillectomy
Study Plan
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 |
---|---|
Other: patients
each patient will be reviewed twice - first time culture from the tonsills and the second culture from the bucal surface.
|
throat culture - from the tonsills and from the bucal surface
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
positiveGABHS culture from bucal surface in comparisson to positive culture from tonsills
Time Frame: each test will be cultures within 24-48 hours.
|
sensitivity and specificity of culture
|
each test will be cultures within 24-48 hours.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0022-17-BBL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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