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Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface

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ClinicalTrials.gov Identifier: NCT03137823
Recruitment Status : Unknown
Verified July 2018 by Bait Balev Hospital.
Recruitment status was:  Recruiting
First Posted : May 3, 2017
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Bait Balev Hospital

Brief Summary:

Diagnosis of Group A beta hemolytic strep tonsillitis -

  • cultre of tonsills (gold standard)
  • culture from bucal surface (test)

Condition or disease Intervention/treatment Phase
Tonsillitis Tonsillitis Streptococcal Diagnostic Test: throat culture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : May 22, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
patients
each patient will be reviewed twice - first time culture from the tonsills and the second culture from the bucal surface.
Diagnostic Test: throat culture
throat culture - from the tonsills and from the bucal surface




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • tonsills exudates
  • Centor criteria - 2 or more

Exclusion Criteria:

  • tonsillectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137823


Contacts
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Contact: LIMOR ADLER, MD +972-524206797 adler_l@mac.org.il
Contact: MICHAL YANAI +972-7958602 yanai_m@mac.org.il

Locations
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Israel
MACCABI Recruiting
Ofakim, Israel
Contact: LIMOR ADLER, MD    +972524206797    adler_l@mac.org.il   
Sponsors and Collaborators
Bait Balev Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bait Balev Hospital
ClinicalTrials.gov Identifier: NCT03137823    
Other Study ID Numbers: 0022-17-BBL
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Bait Balev Hospital:
diagnosis, tonsillitis, streptococcus, GABHS
Additional relevant MeSH terms:
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Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases