Streptococcal Sore ThroatNCT02068469
In Vitro Diagnostic Device for the Detection of Strep A
An observational study of Streptococcal Sore Throat, run by IQuum, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Streptococcal Sore Throat
- How many people
- 799 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult and Pediatric primary care clinic, walk in clinic
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Subjects treated with antibiotics currently or within the previous 7 days.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Norwich Pediatrics
Norwich, Connecticut, 06360
Plano Pediatrics
Plano, Texas, 75093
Twelve Corners Pediatrics
Rochester, New York, 14618
Meridian Clinical Research
Savannah, Georgia, 31406
Advanced Pediatrics
Vienna, Virginia, 22180
About this study
Official title: Multi-Center Study of an In Vitro Diagnostic Device for the Detection of Strep A
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.
- Conditions
- Streptococcal Sore Throat
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate sensitivity and specificity of the Liat Strep A assay when compared to culture
Measured: Results based on samples collected at initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcal Sore ThroatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 799 participants (actual)
Sponsor and investigators
- Lead sponsor
- IQuum, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche Molecular Systems, Inc
- Responsible party
- Sponsor
- Investigators
- Lingjun Chen, BS, Study director, IQuum COO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068469
- Sponsor's protocol ID
- SASA 4.0
- Status last verified
- Aug 2016
- First submitted
- 14 Feb 2014
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Study of an In Vitro Diagnostic Device for the Detection of Strep A
- ClinicalTrials.gov ID
- NCT02068469
- Acronym / sponsor ID
- SASA 4.0
- Conditions
- Streptococcal Sore Throat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 799 participants (actual)
- Lead sponsor
- IQuum, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Roche Molecular Systems, Inc
- Study start
- Dec 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and Pediatric primary care clinic, walk in clinic
Key inclusion criteria (9 listed)
- Subjects who are 3 years of age or older
- Subjects exhibiting symptoms characteristic of pharyngitis, possibly Streptococcus A, including:
- Subjects who are able to understand and consent to participation; for minors under the age of 18, this includes parent or legal guardian
Key exclusion criteria (1 listed)
- Subjects treated with antibiotics currently or within the previous 7 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate sensitivity and specificity of the Liat Strep A assay when compared to culture
Time frame: Results based on samples collected at initial visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lingjun Chen, BS study director
IQuum COO
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcal Sore Throat, run by IQuum, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate sensitivity and specificity of the Liat Strep A assay when compared to culture (time frame: Results based on samples collected at initial visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.