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

Sponsor

Bait Balev Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03137823

Collaborator

(none)

100

Enrollment

Location

Arm

19.3

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Nov 22, 2017

Anticipated Primary Completion Date :

May 22, 2019

Anticipated Study Completion Date :

Jul 1, 2019

Arms and Interventions

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.	Diagnostic Test: throat culture throat culture - from the tonsills and from the bucal surface

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.

Diagnostic Test: throat culture

throat culture - from the tonsills and from the bucal surface

Outcome Measures

Primary Outcome Measures

positiveGABHS culture from bucal surface in comparisson to positive culture from tonsills [each test will be cultures within 24-48 hours.]
sensitivity and specificity of culture

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

tonsills exudates
Centor criteria - 2 or more

Exclusion Criteria:

tonsillectomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MACCABI	Ofakim		Israel

Sponsors and Collaborators

Bait Balev Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bait Balev Hospital

ClinicalTrials.gov Identifier:

NCT03137823

Other Study ID Numbers:

0022-17-BBL

First Posted:

May 3, 2017

Last Update Posted:

Jul 11, 2018

Last Verified:

Jul 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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.:

Keywords provided by Bait Balev Hospital

diagnosis, tonsillitis, streptococcus, GABHS

Additional relevant MeSH terms:

Tonsillitis

Study Results

No Results Posted as of Jul 11, 2018