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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

Tracking Information
First Submitted Date  ICMJE March 16, 2017
First Posted Date  ICMJE May 3, 2017
Last Update Posted Date July 11, 2018
Actual Study Start Date  ICMJE November 22, 2017
Estimated Primary Completion Date May 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface
Official Title  ICMJE Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Tonsillitis
  • Tonsillitis Streptococcal
Intervention  ICMJE Diagnostic Test: throat culture
throat culture - from the tonsills and from the bucal surface
Study Arms  ICMJE patients
each patient will be reviewed twice - first time culture from the tonsills and the second culture from the bucal surface.
Intervention: Diagnostic Test: throat culture
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 30, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2019
Estimated Primary Completion Date May 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • tonsills exudates
  • Centor criteria - 2 or more

Exclusion Criteria:

  • tonsillectomy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03137823
Other Study ID Numbers  ICMJE 0022-17-BBL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bait Balev Hospital
Study Sponsor  ICMJE Bait Balev Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bait Balev Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP