PharyngitisNCT02494219
Pharyngitis,Group A Streptococcal Infection,Rapid Streptococcal Test,Throat Swab Culture
A study testing Rapid Immunochromatographic streptococcal test in people with Pharyngitis, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Comparison of Immunochromatographic Test for rapid detection of group A streptococcal antigen with culture in Pediatric patients. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Pharyngitis
- What is being tested?
- Rapid Immunochromatographic streptococcal test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 906 participants
- Where
- 1 siteQatar
- Study dates
- Jan 2008to Dec 2010
- Phase
- Interventional
- 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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients presenting with the possible diagnosis of Bacterial pharyngitis,between 1-14 years of age.
Who cannot join
- Patients who received antibiotics within two weeks from presentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Immunochromatographic Test for Rapid Detection of Group A Streptococcal Antigen With Culture in Pediatric Patients
Comparison of Immunochromatographic Test for rapid detection of group A streptococcal antigen with culture in Pediatric patients.
Read the detailed description
Throat swabbing by two port germ Amines agar (copan) swabs,then the swabs were randomly labeled as swab A and swab B.Swab A was processed for rapid streptococcal test and swab B was processed for culture in Colombia blood agar.All patients were followed up after 48-72 hours with the final culture results that ultimately determined the need to continue or discontinue treatment.
- Conditions
- Pharyngitis
- Being tested
- Rapid Immunochromatographic streptococcal test
- Keywords
- Group A streptococcal pharyngitis, Rapid streptococcal test, Throat swab culture
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Immunochromatographic streptococcal testProcedure or surgery
Throat swab obtained for rapid strep test in addition to throat culture,in order to check the accuracy of Rapid Immunochromatographic streptococcal test in detection of streptococcal pharyngitis
| Study group | Role | What they receive |
|---|---|---|
| Rapid Immunochromatographic Streptococcal test | Experimental | Throat swabbing by two port germ Amines agar (copan) swabs,the swabs were randomly labeled as swab A and swab B.Swab A was processed for rapid streptococcal test and swab B was processed for culture in Colombia blood agar.All patients were followed up after 48-72 hours with the final culture results that ultimately determined the need to continue or discontinue treatment. Receives: Procedure: Rapid Immunochromatographic streptococcal test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of true negative rapid immunochromatographic strep test when compared throat culture
Measured: upto 48 hours
Secondary outcomes (1)
The ratio of true positive rapid immunochromatographic strep test when compared to throat culture
Measured: upto 48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJan 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharyngitisStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 906 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494219
- Sponsor's protocol ID
- HamadMC
- Status last verified
- Jun 2015
- First submitted
- 18 Jun 2015
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immunochromatographic Test for Rapid Detection of Group A Streptococcal Antigen With Culture in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02494219
- Acronym / sponsor ID
- HamadMC
- Conditions
- Pharyngitis
- Keywords
- Group A streptococcal pharyngitis, Rapid streptococcal test, Throat swab culture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 906 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Jul 2015 (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.
Comparison of Immunochromatographic Test for rapid detection of group A streptococcal antigen with culture in Pediatric patients.
Detailed description
Throat swabbing by two port germ Amines agar (copan) swabs,then the swabs were randomly labeled as swab A and swab B.Swab A was processed for rapid streptococcal test and swab B was processed for culture in Colombia blood agar.All patients were followed up after 48-72 hours with the final culture results that ultimately determined the need to continue or discontinue treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapid Immunochromatographic Streptococcal test | Experimental | Procedure: Rapid Immunochromatographic streptococcal testThroat swabbing by two port germ Amines agar (copan) swabs,the swabs were randomly labeled as swab A and swab B.Swab A was processed for rapid streptococcal test and swab B was processed for culture in Colombia blood agar.All patients were followed up after 48-72 hours with the final culture results that ultimately determined the need to continue or discontinue treatment. |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patients presenting with the possible diagnosis of Bacterial pharyngitis,between 1-14 years of age.
Key exclusion criteria (1 listed)
- Patients who received antibiotics within two weeks from presentation
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 Immunochromatographic streptococcal testThroat swab obtained for rapid strep test in addition to throat culture,in order to check the accuracy of Rapid Immunochromatographic streptococcal test in detection of streptococcal pharyngitis | Procedure or surgery | Rapid Immunochromatographic Streptococcal test |
Primary outcome
The ratio of true negative rapid immunochromatographic strep test when compared throat culture
Time frame: upto 48 hours
1 secondary outcome
The ratio of true positive rapid immunochromatographic strep test when compared to throat culture
Time frame: upto 48hours
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 10 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Immunochromatographic streptococcal test in people with Pharyngitis, run by Hamad Medical Corporation at 1 site in Qatar.
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 1 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 10 Jul 2015. 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 Qatar. 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?
The ratio of true negative rapid immunochromatographic strep test when compared throat culture (time frame: upto 48 hours). 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 10 Jul 2015.