Back to resultsDiagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface
Primary Purpose
Tonsillitis, Tonsillitis Streptococcal
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
throat culture
Sponsored by
About this trial
This is an interventional diagnostic trial for Tonsillitis focused on measuring diagnosis, tonsillitis, streptococcus, GABHS
Eligibility Criteria
Inclusion Criteria:
- tonsills exudates
- Centor criteria - 2 or more
Exclusion Criteria:
- tonsillectomy
Sites / Locations
- MACCABIRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patients
Arm Description
each patient will be reviewed twice - first time culture from the tonsills and the second culture from the bucal surface.
Outcomes
Primary Outcome Measures
positiveGABHS culture from bucal surface in comparisson to positive culture from tonsills
sensitivity and specificity of culture
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03137823
Brief Title
Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface
Official Title
Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 22, 2017 (Actual)
Primary Completion Date
May 22, 2019 (Anticipated)
Study Completion Date
July 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bait Balev Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Diagnosis of Group A beta hemolytic strep tonsillitis -
cultre of tonsills (gold standard)
culture from bucal surface (test)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillitis, Tonsillitis Streptococcal
Keywords
diagnosis, tonsillitis, streptococcus, GABHS
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients
Arm Type
Other
Arm Description
each patient will be reviewed twice - first time culture from the tonsills and the second culture from the bucal surface.
Intervention Type
Diagnostic Test
Intervention Name(s)
throat culture
Intervention Description
throat culture - from the tonsills and from the bucal surface
Primary Outcome Measure Information:
Title
positiveGABHS culture from bucal surface in comparisson to positive culture from tonsills
Description
sensitivity and specificity of culture
Time Frame
each test will be cultures within 24-48 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
tonsills exudates
Centor criteria - 2 or more
Exclusion Criteria:
tonsillectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LIMOR ADLER, MD
Phone
+972-524206797
Email
adler_l@mac.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
MICHAL YANAI
Phone
+972-7958602
Email
yanai_m@mac.org.il
Facility Information:
Facility Name
MACCABI
City
Ofakim
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LIMOR ADLER, MD
Phone
+972524206797
Email
adler_l@mac.org.il
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32216750
Citation
Adler L, Parizade M, Koren G, Yehoshua I. Oral cavity swabbing for diagnosis of group a Streptococcus: a prospective study. BMC Fam Pract. 2020 Mar 26;21(1):57. doi: 10.1186/s12875-020-01129-6.
Results Reference
derived
Learn more about this trial
Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface
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