Streptococcal InfectionsNCT03055728
Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis
An observational study of Streptococcal Infections, run by Georgetown University at 1 site in United States.
Trial summary
The purpose of this study is to determine if the rapid antigen detection test for Group A streptococcal pharyngitis diagnosis might yield higher rates of false positive results in patients who have been treated for GAS pharyngitis within 28 days of the test. Read more about this study
- Who is it for?
- Ages 2 to 20 years
- Conditions the study is for
- Streptococcal Infections
- What is being tested?
- Rapid strep antigen detection test and throat culture
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2013to 16 Jan 2018
- 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 2 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The participants in the study will include 600 children, aged 2 to 20 years old, selected from a private practice in Northern Virginia who present to the practice with signs or symptoms suggestive of acute pharyngitis. Potential subjects who have been treated with less than 10 days of antibiotic therapy, patients who report non-compliance with previous antibiotic therapy, patients who have already been included in the study and children with evidence of GAS carrier status will be excluded.
Who may be able to join
- 2-20 years old
- Current signs and symptoms suggestive of acute pharyngitis, including sore throat, fever, abdominal pain and cervical lymphadenitis.
Who cannot join
- Potential subjects who have been treated with less than 10 days of antibiotic therapy
- Patients who report non-compliance with previous antibiotic therapy
- Patients who have already been included in the study and children with evidence of GAS carrier status
Trial locations and contacts
1 site in 1 country.
United States1 site
Northern Virginia Pediatrics
Falls Church, Virginia, 22046
About this study
The purpose of this study is to determine if the rapid antigen detection test for Group A streptococcal pharyngitis diagnosis might yield higher rates of false positive results in patients who have been treated for GAS pharyngitis within 28 days of the test.
Read the detailed description
Strep pharyngitis, or strep throat, is a common infection afflicting children, aged 2 and above. Testing for strep pharyngitis consists of a rapid test and/or a throat culture. However, it has been observed that rapid testing may not be accurate in children with a recent history of strep pharyngitis. Therefore, this study aims to determine the accuracy of rapid strep testing in children who are presenting with symptoms of strep throat, who also have a recent history of and treatment for strep pharyngitis. By demonstrating an inaccuracy in rapid strep testing in patients with a recent history of strep pharyngitis, unnecessary testing and antibiotic use may be decreased, thereby reducing costs, overuse of antibiotics, and antibiotic resistance.
The participants in the study will include 600 children, aged 2 to 20 years old, selected from a private practice in Northern Virginia who present to the practice with signs or symptoms suggestive of acute pharyngitis. Subjects are children who are presenting with signs and symptoms suggestive of acute pharyngitis by the Centor criteria, including sore throat, fever, abdominal pain and cervical lymphadenitis. Any child with above presenting symptoms who is to undergo Streptococcus rapid antigen testing will be recruited to participate in the study.
A letter of consent will be provided to the parents and guardians of the involved child, stating that the study will be voluntary and confidential, and that all results will be kept in a safe environment.
Investigators will be testing the difference between two proportions, the false positive rate in previously treated compared to those not treated.
- Conditions
- Streptococcal Infections
- Being tested
- Rapid strep antigen detection test, throat culture
- Keywords
- streptococcal infections, rapid strep testing, rapid antigen detection test
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid strep antigen detection testDiagnostic test
Also called rapid strep
Pharyngeal swab for rapid antigen detection of streptococcus
throat cultureDiagnostic test
Pharyngeal swab for culture for bacteria (specifically streptococcus) presence
| Study group | Role | What they receive |
|---|---|---|
| Group 1 / Study Group | Subjects presenting with signs or symptoms of acute pharyngitis, with a history of culture-proven GAS infection and subsequent 10-day antibiotic treatment within the preceding 28 days. Subjects will have a rapid strep antigen detection test and a throat culture to determine presence of strep. Receives: Diagnostic Test: Rapid strep antigen detection test; Diagnostic Test: throat culture | |
| Group 2 / Control Group | Subjects presenting with signs or symptoms of acute pharyngitis, without a recent history of GAS infection. Subjects will have a rapid strep antigen detection test and a throat culture to determine presence of strep. Receives: Diagnostic Test: Rapid strep antigen detection test; Diagnostic Test: throat culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of false positives and false negatives in rapid antigen testing compared to throat culture
The primary objective is to use rapid antigen test results to compare the sensitivity and specificity of rapid antigen testing in children with symptoms of pharyngitis with and without a recent history of Group A streptococcus pharyngitis.
Measured: 48-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start9 May 2013
- Primary completion16 Jan 2018
- Study completion16 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Streptococcal InfectionsStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amin Barakat, MD, Principal investigator, Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055728
- Sponsor's protocol ID
- 2013-0388
- Status last verified
- Jun 2018
- First submitted
- 9 Feb 2017
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sheeler RD, Houston MS, Radke S, Dale JC, Adamson SC. Accuracy of rapid strep testing in patients who have had recent streptococcal pharyngitis. J Am Board Fam Pract. 2002 Jul-Aug;15(4):261-5.
PubMed 12150457Edmonson MB, Farwell KR. Relationship between the clinical likelihood of group a streptococcal pharyngitis and the sensitivity of a rapid antigen-detection test in a pediatric practice. Pediatrics. 2005 Feb;115(2):280-5. doi: 10.1542/peds.2004-0907.
PubMed 15687433McIsaac WJ, White D, Tannenbaum D, Low DE. A clinical score to reduce unnecessary antibiotic use in patients with sore throat. CMAJ. 1998 Jan 13;158(1):75-83.
PubMed 9475915Llor C, Calvino O, Hernandez S, Crispi S, Perez-Bauer M, Fernandez Y, Martinez T, Gomez FF, Cots JM. Repetition of the rapid antigen test in initially negative supposed streptococcal pharyngitis is not necessary in adults. Int J Clin Pract. 2009 Sep;63(9):1340-4. doi: 10.1111/j.1742-1241.2009.02048.x.
PubMed 19691618Leung AK, Newman R, Kumar A, Davies HD. Rapid antigen detection testing in diagnosing group A beta-hemolytic streptococcal pharyngitis. Expert Rev Mol Diagn. 2006 Sep;6(5):761-6. doi: 10.1586/14737159.6.5.761.
PubMed 17009909
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Strep Testing in Children With Recent Streptococcal Pharyngitis
- ClinicalTrials.gov ID
- NCT03055728
- Acronym / sponsor ID
- 2013-0388
- Conditions
- Streptococcal Infections
- Keywords
- streptococcal infections, rapid strep testing, rapid antigen detection test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 9 May 2013 (actual)
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 16 Jan 2018 (actual)
- First posted
- 16 Feb 2017 (actual)
- 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 determine if the rapid antigen detection test for Group A streptococcal pharyngitis diagnosis might yield higher rates of false positive results in patients who have been treated for GAS pharyngitis within 28 days of the test.
Detailed description
Strep pharyngitis, or strep throat, is a common infection afflicting children, aged 2 and above. Testing for strep pharyngitis consists of a rapid test and/or a throat culture. However, it has been observed that rapid testing may not be accurate in children with a recent history of strep pharyngitis. Therefore, this study aims to determine the accuracy of rapid strep testing in children who are presenting with symptoms of strep throat, who also have a recent history of and treatment for strep pharyngitis. By demonstrating an inaccuracy in rapid strep testing in patients with a recent history of strep pharyngitis, unnecessary testing and antibiotic use may be decreased, thereby reducing costs, overuse of antibiotics, and antibiotic resistance.
The participants in the study will include 600 children, aged 2 to 20 years old, selected from a private practice in Northern Virginia who present to the practice with signs or symptoms suggestive of acute pharyngitis. Subjects are children who are presenting with signs and symptoms suggestive of acute pharyngitis by the Centor criteria, including sore throat, fever, abdominal pain and cervical lymphadenitis. Any child with above presenting symptoms who is to undergo Streptococcus rapid antigen testing will be recruited to participate in the study.
A letter of consent will be provided to the parents and guardians of the involved child, stating that the study will be voluntary and confidential, and that all results will be kept in a safe environment.
Investigators will be testing the difference between two proportions, the false positive rate in previously treated compared to those not treated.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 / Study Group | – | Diagnostic Test: Rapid strep antigen detection test, Diagnostic Test: throat cultureSubjects presenting with signs or symptoms of acute pharyngitis, with a history of culture-proven GAS infection and subsequent 10-day antibiotic treatment within the preceding 28 days. Subjects will have a rapid strep antigen detection test and a throat culture to determine presence of strep. |
| Group 2 / Control Group | – | Diagnostic Test: Rapid strep antigen detection test, Diagnostic Test: throat cultureSubjects presenting with signs or symptoms of acute pharyngitis, without a recent history of GAS infection. Subjects will have a rapid strep antigen detection test and a throat culture to determine presence of strep. |
Who may qualify
- Ages
- 2 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The participants in the study will include 600 children, aged 2 to 20 years old, selected from a private practice in Northern Virginia who present to the practice with signs or symptoms suggestive of acute pharyngitis. Potential subjects who have been treated with less than 10 days of antibiotic therapy, patients who report non-compliance with previous antibiotic therapy, patients who have already been included in the study and children with evidence of GAS carrier status will be excluded.
Key inclusion criteria (2 listed)
- 2-20 years old
- Current signs and symptoms suggestive of acute pharyngitis, including sore throat, fever, abdominal pain and cervical lymphadenitis.
Key exclusion criteria (3 listed)
- Potential subjects who have been treated with less than 10 days of antibiotic therapy
- Patients who report non-compliance with previous antibiotic therapy
- Patients who have already been included in the study and children with evidence of GAS carrier status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid strep antigen detection testAlso: rapid strepPharyngeal swab for rapid antigen detection of streptococcus | Diagnostic test | Group 1 / Study Group, Group 2 / Control Group |
| throat culturePharyngeal swab for culture for bacteria (specifically streptococcus) presence | Diagnostic test | Group 1 / Study Group, Group 2 / Control Group |
Primary outcome
Rate of false positives and false negatives in rapid antigen testing compared to throat culture
Time frame: 48-72 hours
The primary objective is to use rapid antigen test results to compare the sensitivity and specificity of rapid antigen testing in children with symptoms of pharyngitis with and without a recent history of Group A streptococcus pharyngitis.
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 7 Jun 2018.
- Background: PubMed 12150457Sheeler RD, Houston MS, Radke S, Dale JC, Adamson SC. Accuracy of rapid strep testing in patients who have had recent streptococcal pharyngitis. J Am Board Fam Pract. 2002 Jul-Aug;15(4):261-5.
- Background: PubMed 15687433Edmonson MB, Farwell KR. Relationship between the clinical likelihood of group a streptococcal pharyngitis and the sensitivity of a rapid antigen-detection test in a pediatric practice. Pediatrics. 2005 Feb;115(2):280-5. doi: 10.1542/peds.2004-0907.
- Background: PubMed 9475915McIsaac WJ, White D, Tannenbaum D, Low DE. A clinical score to reduce unnecessary antibiotic use in patients with sore throat. CMAJ. 1998 Jan 13;158(1):75-83.
- Background: PubMed 19691618Llor C, Calvino O, Hernandez S, Crispi S, Perez-Bauer M, Fernandez Y, Martinez T, Gomez FF, Cots JM. Repetition of the rapid antigen test in initially negative supposed streptococcal pharyngitis is not necessary in adults. Int J Clin Pract. 2009 Sep;63(9):1340-4. doi: 10.1111/j.1742-1241.2009.02048.x.
- Background: PubMed 17009909Leung AK, Newman R, Kumar A, Davies HD. Rapid antigen detection testing in diagnosing group A beta-hemolytic streptococcal pharyngitis. Expert Rev Mol Diagn. 2006 Sep;6(5):761-6. doi: 10.1586/14737159.6.5.761.
- 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.
Amin Barakat, MD principal investigator
Georgetown University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcal Infections, run by Georgetown University at 1 site 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 2 inclusion and 3 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 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Rate of false positives and false negatives in rapid antigen testing compared to throat culture (time frame: 48-72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03055728, which also lists 5 linked publications.
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 7 Jun 2018.