NCT03137823

Brief Summary

Diagnosis of Group A beta hemolytic strep tonsillitis -

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

November 22, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

1.5 years

First QC Date

March 16, 2017

Last Update Submit

July 10, 2018

Conditions

TonsillitisTonsillitis Streptococcal

Keywords

diagnosis, tonsillitis, streptococcus, GABHS

Outcome Measures

Primary Outcomes (1)

  • positiveGABHS culture from bucal surface in comparisson to positive culture from tonsills

    sensitivity and specificity of culture

    each test will be cultures within 24-48 hours.

Study Arms (1)

patients

OTHER

each patient will be reviewed twice - first time culture from the tonsills and the second culture from the bucal surface.

Diagnostic Test: throat culture

Interventions

throat cultureDIAGNOSTIC_TEST

throat culture - from the tonsills and from the bucal surface

patients

Eligibility Criteria

Age3 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • tonsills exudates
  • Centor criteria - 2 or more

You may not qualify if:

  • tonsillectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MACCABI

Ofakim, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32216750DERIVED

MeSH Terms

Conditions

TonsillitisDisease

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

LIMOR ADLER, MD

CONTACT

+972-524206797adler_l@mac.org.il

MICHAL YANAI

CONTACT

+972-7958602yanai_m@mac.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2017

First Posted

May 3, 2017

Study Start

November 22, 2017

Primary Completion

May 22, 2019

Study Completion

July 1, 2019

Last Updated

July 11, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)