TonsillitisNCT03137823
Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface
A study testing throat culture in people with Tonsillitis and Tonsillitis Streptococcal, run by Bait Balev Hospital at 1 site in Israel.
Trial summary
Diagnosis of Group A beta hemolytic strep tonsillitis - cultre of tonsills (gold standard) culture from bucal surface (test) Read more about this study
- Who is it for?
- Ages 3 to 65 years
- Conditions the study is for
- Tonsillitis, Tonsillitis Streptococcal
- What is being tested?
- throat culture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Nov 2017to 1 Jul 2019
- 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 3 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- tonsills exudates
- Centor criteria - 2 or more
Who cannot join
- tonsillectomy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
MACCABI
Ofakim
LIMOR ADLER, MD, +972524206797, adler_l@mac.org.il
About this study
Diagnosis of Group A beta hemolytic strep tonsillitis -
- cultre of tonsills (gold standard)
- culture from bucal surface (test)
Read the detailed description
This study will examine 2 groups. first group of 50 children aged 3-18 years and the second group of adults aged 18-65 with a clinical diagnosis of tonsillitis and centor criteria of 2 or more (fever, exudates on tonsills, no cough, enlarged lymph nodes).
In each patient we'll take 2 cultures - the first from the tonsills and the second from the bucal surface. both of them will be sent to MEGA-LAB .
the treatment will be based only on the gold standrad culture from the tonsills.
- Conditions
- Tonsillitis, Tonsillitis Streptococcal
- Being tested
- throat culture
- Keywords
- diagnosis, tonsillitis, streptococcus, GABHS
- Medical subject headings
- Tonsillitis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
throat cultureDiagnostic test
throat culture - from the tonsills and from the bucal surface
| Study group | Role | What they receive |
|---|---|---|
| patients | Other | each patient will be reviewed twice - first time culture from the tonsills and the second culture from the bucal surface. Receives: Diagnostic Test: throat culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
positiveGABHS culture from bucal surface in comparisson to positive culture from tonsills
sensitivity and specificity of culture
Measured: each test will be cultures within 24-48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start22 Nov 2017
- Primary completion22 May 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TonsillitisStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bait Balev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137823
- Sponsor's protocol ID
- 0022-17-BBL
- Status last verified
- Jul 2018
- First submitted
- 16 Mar 2017
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adler L, Parizade M, Koren G, Yehoshua I. Oral cavity swabbing for diagnosis of group a Streptococcus: a prospective study. BMC Fam Pract. 2020 Mar 26;21(1):57. doi: 10.1186/s12875-020-01129-6.
PubMed 32216750
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface
- ClinicalTrials.gov ID
- NCT03137823
- Acronym / sponsor ID
- 0022-17-BBL
- Conditions
- Tonsillitis, Tonsillitis Streptococcal
- Keywords
- diagnosis, tonsillitis, streptococcus, GABHS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bait Balev HospitalUniversity, hospital or other
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 22 May 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 3 May 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.
Diagnosis of Group A beta hemolytic strep tonsillitis -
- cultre of tonsills (gold standard)
- culture from bucal surface (test)
Detailed description
This study will examine 2 groups. first group of 50 children aged 3-18 years and the second group of adults aged 18-65 with a clinical diagnosis of tonsillitis and centor criteria of 2 or more (fever, exudates on tonsills, no cough, enlarged lymph nodes).
In each patient we'll take 2 cultures - the first from the tonsills and the second from the bucal surface. both of them will be sent to MEGA-LAB .
the treatment will be based only on the gold standrad culture from the tonsills.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Other | Diagnostic Test: throat cultureeach patient will be reviewed twice - first time culture from the tonsills and the second culture from the bucal surface. |
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- tonsills exudates
- Centor criteria - 2 or more
Key exclusion criteria (1 listed)
- tonsillectomy
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 |
|---|---|---|
| throat culturethroat culture - from the tonsills and from the bucal surface | Diagnostic test | patients |
Primary outcome
positiveGABHS culture from bucal surface in comparisson to positive culture from tonsills
Time frame: each test will be cultures within 24-48 hours.
sensitivity and specificity of culture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Derived from this study: PubMed 32216750Adler L, Parizade M, Koren G, Yehoshua I. Oral cavity swabbing for diagnosis of group a Streptococcus: a prospective study. BMC Fam Pract. 2020 Mar 26;21(1):57. doi: 10.1186/s12875-020-01129-6.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing throat culture in people with Tonsillitis and Tonsillitis Streptococcal, run by Bait Balev Hospital at 1 site in Israel.
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 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 11 Jul 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 Israel. 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?
Contact LIMOR ADLER, MD (+972-524206797, adler_l@mac.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positiveGABHS culture from bucal surface in comparisson to positive culture from tonsills (time frame: each test will be cultures within 24-48 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 NCT03137823, which also lists 1 linked publication.
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 11 Jul 2018.