Group A Streptococcal InfectionNCT03693495
Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis
A study testing ellume·lab Group A Streptococcus Test, Bacterial Culture and Polymerase Chain Reaction (PCR) in people with Group A Streptococcal Infection, run by Ellume Pty Ltd at 4 sites in New Zealand.
Trial summary
Participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Group A Streptococcal Infection
- What is being tested?
- ellume·lab Group A Streptococcus Test, Bacterial Culture and Polymerase Chain Reaction (PCR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesNew Zealand
- Study dates
- Sep 2018to Mar 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female participants aged 3 years of age or older
- Must currently be presenting with symptoms characteristic of pharyngitis, possibly Group A Strep, including:
- Acute onset of sore throat;
- Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation and;
- At least one of the following:
- Red and swollen/inflamed tonsils (or fossae);
Show all 10Show fewer
- Pharyngeal or tonsillar exudate; o Cervical lymphadenopathy
- ≤ 14 days from onset of signs and symptoms of pharyngitis
- Parent/legal guardian of Participants < 18 years of age capable and willing to give informed consent
- Participants ≥18 years of age capable and willing to give informed consent
Who cannot join
- Participants < 3 years of age
- Participants undergoing treatment with antibiotics, or those who have undergone treatment with antibiotics for current episode of pharyngitis
- Currently enrolled in another clinical trial or used any investigational device within 30 days preceding informed consent
- Participants 18 years of age or older unable to understand English and consent to participation
- Parent/legal guardian of Participants < 18 years of age unable to understand English and consent to participation of child
- Prior enrollment in this clinical validation study
Trial locations and contacts
4 sites in 1 country.
New Zealand4 sites
Optimal Clinical Trials
Grafton, Auckland, 1010
Totara Clinical Research Ltd
New Lynn, Auckland, 0600
Papamoa Pines Medical Centre
Papamoa, Tauranga, 3118
Lakeland Clinical Trials
Rotorua, 3010
About this study
Official title: A Prospective Multi-Centre Study of the Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis
Participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days. Enrolment visit (Day 1) assessments for all participants will include the collection of throat swabs, testing by staff at the site using the ellume·lab Group A Strep Test and testing for Group A Streptococcus by a central laboratory using bacterial culture and polymerase chain reaction (PCR). All participants will be followed up with a phone assessment of adverse events between Days 2-14.
- Conditions
- Group A Streptococcal Infection
- Being tested
- ellume·lab Group A Streptococcus Test, Bacterial Culture, Polymerase Chain Reaction (PCR)
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ellume·lab Group A Streptococcus TestDiagnostic test
ellume.lab Group A Streptococcus Test is a rapid diagnostic test intended to be used as an aid in the diagnosis of Group A Streptococcus in symptomatic participants. The sample type used is a throat swab.
Bacterial CultureDiagnostic test
Pharyngeal swab is collected from participant and this specimen is inoculated into 5% sheep blood agar plates. Beta-haemolytic colonies are isolated, followed by latex agglutination test.
Polymerase Chain Reaction (PCR)Diagnostic test
Polymerase Chain Reaction (PCR) is a molecular diagnostic technique for the detection and identification of Group A Streptococcus, both for clinical samples and isolates. Polymerase Chain Reaction (PCR) allows template bacterial RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.
| Study group | Role | What they receive |
|---|---|---|
| ellume·lab Group A Streptococcus Test | Experimental | ellume·lab Group A Streptococcus Test
Pharyngeal samples from participants will be tested with:
ellume.lab Group A Streptococcus Test; Polymerase Chain Reaction (PCR) and bacterial culture. Receives: Diagnostic Test: ellume·lab Group A Streptococcus Test; Diagnostic Test: Bacterial Culture; Diagnostic Test: Polymerase Chain Reaction (PCR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals
Measured: 1 Week
The specificity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals
Measured: 1 Week
Secondary outcomes (3)
The sensitivity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to PCR
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals
Measured: 1 Week
The specificity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to PCR
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals
Measured: 1 Week
Ease of use as assessed by operator questionnaire
The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale).
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study startSep 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Why it stopped: Study was cancelled before enrollment for reasons not related to safety and performance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group A 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellume Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barnaby H Montgomery, Principal investigator, Optimal Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693495
- Sponsor's protocol ID
- E-GAS-NZ-1807
- Status last verified
- Jan 2019
- First submitted
- 1 Oct 2018
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-Centre Study of the Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis
- ClinicalTrials.gov ID
- NCT03693495
- Acronym / sponsor ID
- E-GAS-NZ-1807
- Conditions
- Group A Streptococcal Infection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was cancelled before enrollment for reasons not related to safety and performance.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ellume Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 3 Oct 2018 (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.
Participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days. Enrolment visit (Day 1) assessments for all participants will include the collection of throat swabs, testing by staff at the site using the ellume·lab Group A Strep Test and testing for Group A Streptococcus by a central laboratory using bacterial culture and polymerase chain reaction (PCR). All participants will be followed up with a phone assessment of adverse events between Days 2-14.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ellume·lab Group A Streptococcus Test | Experimental | Diagnostic Test: ellume·lab Group A Streptococcus Test, Diagnostic Test: Bacterial Culture, Diagnostic Test: Polymerase Chain Reaction (PCR)ellume·lab Group A Streptococcus Test Pharyngeal samples from participants will be tested with: ellume.lab Group A Streptococcus Test; Polymerase Chain Reaction (PCR) and bacterial culture. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female participants aged 3 years of age or older
- Must currently be presenting with symptoms characteristic of pharyngitis, possibly Group A Strep, including:
- ≤ 14 days from onset of signs and symptoms of pharyngitis
- Parent/legal guardian of Participants < 18 years of age capable and willing to give informed consent
- Participants ≥18 years of age capable and willing to give informed consent
Key exclusion criteria (6 listed)
- Participants < 3 years of age
- Participants undergoing treatment with antibiotics, or those who have undergone treatment with antibiotics for current episode of pharyngitis
- Currently enrolled in another clinical trial or used any investigational device within 30 days preceding informed consent
- Participants 18 years of age or older unable to understand English and consent to participation
- Parent/legal guardian of Participants < 18 years of age unable to understand English and consent to participation of child
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 |
|---|---|---|
| ellume·lab Group A Streptococcus Testellume.lab Group A Streptococcus Test is a rapid diagnostic test intended to be used as an aid in the diagnosis of Group A Streptococcus in symptomatic participants. The sample type used is a throat swab. | Diagnostic test | ellume·lab Group A Streptococcus Test |
| Bacterial CulturePharyngeal swab is collected from participant and this specimen is inoculated into 5% sheep blood agar plates. Beta-haemolytic colonies are isolated, followed by latex agglutination test. | Diagnostic test | ellume·lab Group A Streptococcus Test |
| Polymerase Chain Reaction (PCR)Polymerase Chain Reaction (PCR) is a molecular diagnostic technique for the detection and identification of Group A Streptococcus, both for clinical samples and isolates. Polymerase Chain Reaction (PCR) allows template bacterial RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected. | Diagnostic test | ellume·lab Group A Streptococcus Test |
Primary outcome
The sensitivity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture
Time frame: 1 Week
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals
The specificity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture
Time frame: 1 Week
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals
3 secondary outcomes
The sensitivity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to PCR
Time frame: 1 Week
The specificity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to PCR
Time frame: 1 Week
Ease of use as assessed by operator questionnaire
Time frame: 1 Week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Group A Streptococcal Infection
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
Streptococcal Pharyngitis, Group A Streptococcal Infection
Not yet recruitingPhase 1
Stopping Strep Throat With Antibodies in Healthy Adults.
Streptococcal Pharyngitis
RecruitingPhase 3
Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
Pneumococcal Immunization, Healthy Volunteers
Not yet recruitingPhase 4
Short Versus Standard Amoxicillin for Pediatric Strep Throat
Group A Streptococcal (GAS) Pharyngitis
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.
Barnaby H Montgomery principal investigator
Optimal Clinical Trials
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ellume·lab Group A Streptococcus Test, Bacterial Culture and Polymerase Chain Reaction (PCR) in people with Group A Streptococcal Infection, run by Ellume Pty Ltd at 4 sites in New Zealand.
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 10 inclusion and 6 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: withdrawn, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in New Zealand. 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 was withdrawn before enrolling participants, so there are no results.
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 sensitivity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture (time frame: 1 Week). The study lists 2 primary outcomes in all. 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 16 Jan 2019.