TonsillitisNCT02972437
Detection of Group A Streptococcus (GAS) in Oral Cavity
An observational study of Tonsillitis, run by Hadassah Medical Organization.
Trial summary
The investigators intend to screen children who are suspected of having GAS tonsillitis. From each child we will take a throat culture and saliva sample to screen for molecular evidence of GAS. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Tonsillitis
- What is being tested?
- sample taking
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: children 3-16 years old with evidence of tonsilitis
Who may be able to join
- clinical evidence of GAS tonsillitis
- healthy, no chronic illness
- not a GAS carrier
Who cannot join
- GAS carrier
- Active background disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Detection of Group A Streptococcus (GAS) in Oral Cavity Using Molecular Techniques
The investigators intend to screen children who are suspected of having GAS tonsillitis. From each child we will take a throat culture and saliva sample to screen for molecular evidence of GAS.
- Conditions
- Tonsillitis
- Being tested
- sample taking
- Keywords
- GAS in oral cavity
- Medical subject headings
- Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sample takingOther
throat culture and oral cavity sample
What is being measured
The primary outcome is the main question the study is designed to answer.
molecular detection of GAS compared to throat culture detection
3 days after taking the oral sample, the investigators will compare it to the throat culture taken at the same time.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillitisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972437
- Sponsor's protocol ID
- naamap-HMO-CTIL
- Status last verified
- Nov 2016
- First submitted
- 16 Nov 2016
- Last updated
- 29 Nov 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 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Group A Streptococcus (GAS) in Oral Cavity Using Molecular Techniques
- ClinicalTrials.gov ID
- NCT02972437
- Acronym / sponsor ID
- naamap-HMO-CTIL
- Conditions
- Tonsillitis
- Keywords
- GAS in oral cavity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 23 Nov 2016 (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 investigators intend to screen children who are suspected of having GAS tonsillitis. From each child we will take a throat culture and saliva sample to screen for molecular evidence of GAS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children 3-16 years old with evidence of tonsilitis
Key inclusion criteria (3 listed)
- clinical evidence of GAS tonsillitis
- healthy, no chronic illness
- not a GAS carrier
Key exclusion criteria (2 listed)
- GAS carrier
- Active background disease
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 |
|---|---|---|
| sample takingthroat culture and oral cavity sample | Other | – |
Primary outcome
molecular detection of GAS compared to throat culture detection
Time frame: 3 days
3 days after taking the oral sample, the investigators will compare it to the throat culture taken at the same time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Tonsillitis, run by Hadassah Medical Organization.
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 3 inclusion and 2 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 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact saar hashavya, doctor (972 53 223 3987, saarha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
molecular detection of GAS compared to throat culture detection (time frame: 3 days). 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 29 Nov 2016.