Streptococcal InfectionNCT00527852
Assessment of Flocked Swabs for the Identification of Group A Streptococcal Pharyngitis
A study testing Flocked swab in people with Streptococcal Infection and Pharyngitis, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
This is a study to to compare traditional fibre wound swabs to more recently developed flocked swabs for the identification of Group A streptococcal pharyngitis in children presenting to a children's emergency department. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Streptococcal Infection, Pharyngitis
- What is being tested?
- Flocked swab
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Dec 2007
- 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 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Need for a bacterial throat culture
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's Hospital of Eastern Ontario Emergency Department
Ottawa, Ontario, K1H8L1
About this study
This is a study to to compare traditional fibre wound swabs to more recently developed flocked swabs for the identification of Group A streptococcal pharyngitis in children presenting to a children's emergency department.
- Conditions
- Streptococcal Infection, Pharyngitis
- Being tested
- Flocked swab
- Keywords
- Flocked swab, Group A streptococcus pharyngitis
- Medical subject headings
- Streptococcal Infections, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flocked swabDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Group A streptococcus via culture of organism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcal InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Investigators
- David M Goldfarb, MD FRCPC, Principal investigator, Children's Hospital of Eastern Ontario, Division of Infectious Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527852
- Sponsor's protocol ID
- 07/59X
- Status last verified
- Jul 2007
- First submitted
- 10 Sep 2007
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Flocked Swabs for the Identification of Group A Streptococcal Pharyngitis
- ClinicalTrials.gov ID
- NCT00527852
- Acronym / sponsor ID
- 07/59X
- Conditions
- Streptococcal Infection, Pharyngitis
- Keywords
- Flocked swab, Group A streptococcus pharyngitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Sep 2007 (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.
This is a study to to compare traditional fibre wound swabs to more recently developed flocked swabs for the identification of Group A streptococcal pharyngitis in children presenting to a children's emergency department.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Need for a bacterial throat culture
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Flocked swab | Device | – |
Primary outcome
Identification of Group A streptococcus via culture of organism
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 18 Apr 2018.
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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.
David M Goldfarb, MD FRCPC principal investigator
Children's Hospital of Eastern Ontario, Division of Infectious Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flocked swab in people with Streptococcal Infection and Pharyngitis, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
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 0 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 18 Apr 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 Canada. 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?
Identification of Group A streptococcus via culture of organism. 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 18 Apr 2018.