NCT02068469

Brief Summary

The purpose of this trial is to show the accuracy and specificity of the Liat analyzer and assay for detecting Strep A at the point of care lab compared to culture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
799

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

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

Study Start

First participant enrolled

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

4 months

First QC Date

February 14, 2014

Last Update Submit

August 30, 2016

Conditions

Streptococcal Sore Throat

Outcome Measures

Primary Outcomes (1)

  • Evaluate sensitivity and specificity of the Liat Strep A assay when compared to culture

    Results based on samples collected at initial visit

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult and Pediatric primary care clinic, walk in clinic

You may qualify if:

  • Subjects who are 3 years of age or older
  • Subjects exhibiting symptoms characteristic of pharyngitis, possibly Streptococcus A, including:
  • presence of sore throat, and at least one other symptom from the list below:
  • redness of the posterior pharyngeal wall
  • pharyngeal or tonsillar exudate
  • tonsillar swelling
  • tender cervical lymphadenopathy
  • fever, \>38C at presentation or within the past 24 hours
  • Subjects who are able to understand and consent to participation; for minors under the age of 18, this includes parent or legal guardian

You may not qualify if:

  • Subjects treated with antibiotics currently or within the previous 7 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Norwich Pediatrics

Norwich, Connecticut, 06360, United States

Location

Meridian Clinical Research

Savannah, Georgia, 31406, United States

Location

Twelve Corners Pediatrics

Rochester, New York, 14618, United States

Location

Plano Pediatrics

Plano, Texas, 75093, United States

Location

Advanced Pediatrics

Vienna, Virginia, 22180, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Throat culture swab

Study Officials

  • Lingjun Chen, BS

    IQuum COO

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 14, 2014

First Posted

February 21, 2014

Study Start

December 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

August 31, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(5)