NCT02972437

Brief Summary

The investigators intend to screen children who are suspected of having GAS tonsillitis. From each child we will take a throat culture and saliva sample to screen for molecular evidence of GAS.

Trial Health

35
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 all trials

Timeline
Completed

Started Dec 2016

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

November 16, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

November 16, 2016

Last Update Submit

November 27, 2016

Conditions

Tonsillitis

Keywords

GAS in oral cavity

Outcome Measures

Primary Outcomes (1)

  • molecular detection of GAS compared to throat culture detection

    3 days after taking the oral sample, the investigators will compare it to the throat culture taken at the same time.

    3 days

Interventions

sample takingOTHER

throat culture and oral cavity sample

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children 3-16 years old with evidence of tonsilitis

You may qualify if:

  • clinical evidence of GAS tonsillitis
  • healthy, no chronic illness
  • not a GAS carrier

You may not qualify if:

  • GAS carrier
  • Active background disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tonsillitis

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

saar hashavya, doctor

CONTACT

972 53 223 3987saarha@gmail.com

naama shwartz, doctor

CONTACT

972545216158naamapines@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 23, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

November 29, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share