NCT03231098

Brief Summary

The objective of this study is to investigate the use of patient throat gargle as an alternative to throat swabbing for the diagnosis of pharyngitis caused by Group A β-Hemolytic Streptococcus (GABHS) infection, also known as strep throat.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 23, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

February 12, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2019

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

July 23, 2017

Last Update Submit

December 8, 2019

Conditions

Group A Streptococcus: B Hemolytic Pharyngitis

Outcome Measures

Primary Outcomes (2)

  • Comparative: Method sensitivity to investigate method effectiveness.

    Compare sensitivity of each gargle fluid GABHS detection method.

    Through study completion, about 9 months

  • Comparative: Method specificity to investigate method effectiveness.

    Compare specificity of each gargle fluid GABHS detection method.

    Through study completion, about 9 months

Secondary Outcomes (2)

  • Quantitative: Average GABHS in gargle.

    Through study completion, about 9 months

  • Quantitative: Minimum GABHS in gargle.

    Through study completion, about 9 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients age 18 years and older who present to the study site with complaints of sore throat and are suspected of suffering from GABHS pharyngitis.

You may qualify if:

  • Age 18 years or older.
  • Suspected of suffering from GABHS pharyngitis.
  • Able to communicate with study personnel (English or Hebrew).
  • Able to understand oral and written information about the study.
  • Willing to provide written informed consent to participate in the study.

You may not qualify if:

  • Not capable of gargling 10-15 mL fluid.
  • Diagnosed or self-reported pregnancy.
  • History of dementia, cognitive impairment, or psychiatric or mental disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TEREM Ha'Gdud Ha'Ivri Family Clinic

Jerusalem, 9234502, Israel

Location

Related Publications (1)

  • Karabay O, Ekerbicer H, Yilmaz F. Efficacy of throat gargling for detection of group a beta-hemolytic streptococcus. Jpn J Infect Dis. 2005 Feb;58(1):39-40.

    PMID: 15728991BACKGROUND

Study Officials

  • Avraham Alpert, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2017

First Posted

July 27, 2017

Study Start

February 12, 2018

Primary Completion

February 16, 2019

Study Completion

February 16, 2019

Last Updated

December 10, 2019

Record last verified: 2019-12

Locations

IL(1)