Strep ThroatNCT01491776
Evaluation of the IND One Step Strep A Rapid Test vs. Culture
An observational study of Strep Throat, run by IND Diagnostic Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to demonstrate the ability of the IND One Step Strep A test to accurately test a throat swab specimen from a symptomatic patient for the presence or absence of Group A Streptococcus (Strep A) when compared to culture. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Strep Throat
- How many people
- 315 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2011to Apr 2012
- 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: Male and female subjects, 3 years of age or older, exhibiting symptoms consistent with Strep A infection.
Who may be able to join
- Male and Female subjects three (3) years of age or older
- Patients exhibiting at least 3 of the following symptoms:
- fever
- sore throat
- swollen lymph nodes in the neck
- redness of the throat and tonsils
- white or yellow patches on the tonsils
- Must be able to collect 2 throat swab samples from patient
Who cannot join
- Patients currently undergoing antibiotic treatment will be excluded from study
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Pioneer Clinical Research, LLC
Bellevue, Nebraska, 68005
Andrea Goolsby, LPN-C, CCRC, 402-291-8704, agoolsby.pcr@gmail.com
Darin M. Gregory, MD
- Recruiting
HCCA Clinical Research
Franklin, Tennessee, 37067
Amie Demming, 615-627-1018, ademming@hccacrs.com
Sreedhar (Steve) Samudrala, MD
- Recruiting
HCCA Clinical Research
Smyrna, Tennessee, 37067
Amie Demming, 615-627-1018, ademming@hccacrs.com
Sadia Dar, MD
About this study
Official title: Evaluation of the IND One Step Strep A Rapid Test Versus Culture Using Clinical Throat Swab Samples From Patients With Suspected Strep A Infections, CLIA Waiver Study
The purpose of this study is to demonstrate the ability of the IND One Step Strep A test to accurately test a throat swab specimen from a symptomatic patient for the presence or absence of Group A Streptococcus (Strep A) when compared to culture.
Read the detailed description
Group A Streptococcus is a principal cause of respiratory infections such as tonsillitis, pharyngitis, and scarlet fever. Since pharyngitis can lead to rheumatic fever or acute glomerulonephritis, it is important to differentiate streptococcal pharyngitis from viral disease during early stages of infection. The Strep A Rapid Test is a simple and rapid test which can detect Group A Streptococcal antigen directly from throat swabs allowing physicians to make a rapid diagnosis and to administer therapy immediately. The IND Diagnostic Inc. Strep A Rapid Test is a lateral flow immunoassay utilizing colloidal gold reagents labeled with Strep A antibody. The test detects either viable or nonviable organisms directly from throat swabs within 10 minutes.
- Conditions
- Strep Throat
- Keywords
- Group A Streptococcus, Strep A, Rapid Test, Pharyngitis
- Medical subject headings
- Pharyngitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strep 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
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IND Diagnostic Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darin M. Gregory, MD, Principal investigator, Pioneer Clinical ResearchSadia Dar, MD, Principal investigator, HCCA Clinical ResearchSreedhar (Steve) Samudrala, MD, Principal investigator, HCCA Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491776
- Sponsor's protocol ID
- IND-CSP-2011-01
- Status last verified
- Mar 2012
- First submitted
- 12 Dec 2011
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the IND One Step Strep A Rapid Test Versus Culture Using Clinical Throat Swab Samples From Patients With Suspected Strep A Infections, CLIA Waiver Study
- ClinicalTrials.gov ID
- NCT01491776
- Acronym / sponsor ID
- IND-CSP-2011-01
- Conditions
- Strep Throat
- Keywords
- Group A Streptococcus, Strep A, Rapid Test, Pharyngitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- IND Diagnostic Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 14 Dec 2011 (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 study is to demonstrate the ability of the IND One Step Strep A test to accurately test a throat swab specimen from a symptomatic patient for the presence or absence of Group A Streptococcus (Strep A) when compared to culture.
Detailed description
Group A Streptococcus is a principal cause of respiratory infections such as tonsillitis, pharyngitis, and scarlet fever. Since pharyngitis can lead to rheumatic fever or acute glomerulonephritis, it is important to differentiate streptococcal pharyngitis from viral disease during early stages of infection. The Strep A Rapid Test is a simple and rapid test which can detect Group A Streptococcal antigen directly from throat swabs allowing physicians to make a rapid diagnosis and to administer therapy immediately. The IND Diagnostic Inc. Strep A Rapid Test is a lateral flow immunoassay utilizing colloidal gold reagents labeled with Strep A antibody. The test detects either viable or nonviable organisms directly from throat swabs within 10 minutes.
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
- Male and female subjects, 3 years of age or older, exhibiting symptoms consistent with Strep A infection.
Key inclusion criteria (8 listed)
- Male and Female subjects three (3) years of age or older
- Patients exhibiting at least 3 of the following symptoms:
- Must be able to collect 2 throat swab samples from patient
Key exclusion criteria (1 listed)
- Patients currently undergoing antibiotic treatment will be excluded from study
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
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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.
Darin M. Gregory, MD principal investigator
Pioneer Clinical Research
Sadia Dar, MD principal investigator
HCCA Clinical Research
Sreedhar (Steve) Samudrala, MD principal investigator
HCCA Clinical Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Strep Throat, run by IND Diagnostic Inc. at 3 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 8 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: status not confirmed, as of the sponsor's last update on 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 8 Mar 2012.