Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans)NCT03238274
Sofia 2 Lyme FIA Whole Blood Clinical Study
An observational study of Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans), run by Quidel Corporation at 11 sites in United States.
Trial summary
The objective of this study is to demonstrate the clinical performance of the Sofia® 2 analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to Comparator Method(s) and/or an FDA cleared predicate test(s) using matched finger-stick, whole blood and serum from symptomatic subjects. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans)
- What is being tested?
- Sofia 2 Lyme FIA testing
- Type of treatment
- Medical device
- How many people
- 597 participants
- Where
- 11 sitesUnited States
- Study dates
- 6 Jun 2017to 15 Dec 2017
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Known or suspected exposure or tick-bite from an endemic area prior to onset of symptoms
Who may be able to join
- Arm 1 - Prospective symptomatic subjects, must have had a known or suspected exposure or tick-bite from an endemic area prior to onset of symptoms, and be currently exhibiting the following:
- The physician determines that the subject has an expanding erythema migrans (EM) lesion or "bulls-eye rash" with evidence of clearing in the center and has requested 2 tier serological testing or prescribed a ≥10 day course of antibiotics such as doxycycline in subjects > 8 years old or amoxicillin, cefuroxime or doxycycline in subjects ≤8 years of age:
- Or
- The physician must observe current symptoms, including:
- At least three (3) of the listed acute stage symptoms listed:
- fatigue
Show all 24Show fewer
- night sweats
- chills
- fever
- headache
- arthralgia
- mildly stiff neck
- myalgia i. one or more symptoms a. through h. are determined to be intermittent
- Or,
- at least one (1) of the following current conditions:
- recurrent, brief attacks (weeks/months) of objective joint swelling in one or more joints, sometimes followed by chronic arthritis in one or a few joints,
- lymphocytic meningitis
- cranial neuritis (partial facial palsy and may be bilateral)
- radiculoneuropathy
- encephalomyelitis
- acute onset of high-grade (2nd or 3rd degree) atrioventricular conduction defects that resolve in days to weeks, sometimes associated with myocarditis
- In addition, the physician must be sufficiently confident in the possibility of Lyme disease to have requested two-tier diagnostic testing and/or prescribed a ≥10 day course of antibiotics such as doxycycline in patients > 8 years old or amoxicillin, cefuroxime or doxycycline in patients ≤8 years of age.
- Arm 2 - Previously diagnosed with Lyme disease / confirmed case of Lyme disease: Within the past 16 months, a physician must have previously diagnosed the subject based on the presence of an EM rash or based on symptoms and confirmed by laboratory findings as outlined in the CDC two Tier Testing algorithm. A copy of the subject's medical record documenting the diagnosis must be obtained, and kept as source documentation at the enrolling site.
- Arm 3 - Previously diagnosed with Lyme disease / confirmed case of Lyme disease: Within the past 17 to 50 months, a physician must have previously diagnosed the subject based on the presence of an EM rash or based on symptoms and confirmed by laboratory findings as outlined in the CDC two Tier Testing algorithm. A copy of the subject's medical record documenting the diagnosis must be obtained, and kept as source documentation at the enrolling site.
Who cannot join
- Unable to understand and consent to participation; for minors this includes parent or legal guardian.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Essentia Institute of Rural Health
Duluth, Minnesota, 55805
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Regional Clinical Research
Endwell, New York, 13760
NECCR Primacare Research, LLC
Fall River, Massachusetts, 02721
Harleysville Medical Associates
Harleysville, Pennsylvania, 19438
Lincoln Primary Care
Lincoln, Rhode Island, 02865
Marshfield Clinic Research Institute
Marshfield, Wisconsin, 54449
The Miriam Hospital
Providence, Rhode Island, 02906
Center for Medical Research, LLC
Providence, Rhode Island, 02908
Main Road Family Medicine
South Westport, Massachusetts, 02790
Ocean State Primary Care
Westerly, Rhode Island, 02891
About this study
The objective of this study is to demonstrate the clinical performance of the Sofia® 2 analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to Comparator Method(s) and/or an FDA cleared predicate test(s) using matched finger-stick, whole blood and serum from symptomatic subjects.
Read the detailed description
The objective of this study is to demonstrate the clinical performance of the Sofia® 2 analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to Comparator Method(s) and/or an FDA cleared predicate test(s) using matched finger-stick, whole blood and serum from symptomatic subjects. The finger-stick and venous whole blood specimens will be tested by CLIA waived test operators. The matched plasma (from the leftover whole blood) and serum specimens will be sent to a separate reference laboratory for testing to compare the matched specimen using the Comparator Method(s) and/or an FDA-cleared predicate test(s). The results of this study may be used to support a 510(k) and/or CLIA-Waiver submission for testing whole blood sample types.
- Being tested
- Sofia 2 Lyme FIA testing
- Medical subject headings
- Glossitis, Benign Migratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofia 2 Lyme FIA testingDevice
IVD testing of whole blood or serum/plasma to aid in the detection of anti-B. burgdorferi IgG / IgM antibody
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Arm 1 is a multi-site, single visit, prospective clinical study where subjects will be enrolled based on a physician's assessment of current Lyme specific symptoms from recent contact with a tick. Receives: Device: Sofia 2 Lyme FIA testing | |
| Arm 2 | Arm 2 will consist of subjects selected from a pool of patients that were previously determined to have Lyme disease either by the presence of the diagnostic rash (erythema migrans) or through laboratory findings and physician diagnosis based on patient symptoms. In this Arm the site may recruit by contacting subjects previously diagnosed with Lyme disease no longer than 16 months post diagnosis and no earlier than 1 week post diagnosis. Receives: Device: Sofia 2 Lyme FIA testing | |
| Arm 3 | Arm 3 will consist of subjects selected from a pool of patients that were previously determined to have Lyme disease either by the presence of the diagnostic rash (erythema migrans) or through laboratory findings and physician diagnosis based on patient symptoms. In this Arm the site may recruit by contacting subjects previously diagnosed with Lyme disease between 17 months and 50 months post diagnosis. For the subject to be enrolled, a physician must have diagnosed the subject to have Lyme disease based on clinical symptoms. Receives: Device: Sofia 2 Lyme FIA testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of anti-B. burgdorferi IgG / IgM antibody
Accurate detection of presence or absence of anti-B. burgdorferi IgG / IgM antibody
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start6 Jun 2017
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quidel Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Clement, Study director, Quidel Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238274
- Sponsor's protocol ID
- CS-0267-01
- Status last verified
- Mar 2018
- First submitted
- 1 Aug 2017
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan or intention to share participant data with others.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sofia 2 Lyme FIA Whole Blood Clinical Study
- ClinicalTrials.gov ID
- NCT03238274
- Acronym / sponsor ID
- CS-0267-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Quidel CorporationIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 3 Aug 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.
The objective of this study is to demonstrate the clinical performance of the Sofia® 2 analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to Comparator Method(s) and/or an FDA cleared predicate test(s) using matched finger-stick, whole blood and serum from symptomatic subjects.
Detailed description
The objective of this study is to demonstrate the clinical performance of the Sofia® 2 analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to Comparator Method(s) and/or an FDA cleared predicate test(s) using matched finger-stick, whole blood and serum from symptomatic subjects. The finger-stick and venous whole blood specimens will be tested by CLIA waived test operators. The matched plasma (from the leftover whole blood) and serum specimens will be sent to a separate reference laboratory for testing to compare the matched specimen using the Comparator Method(s) and/or an FDA-cleared predicate test(s). The results of this study may be used to support a 510(k) and/or CLIA-Waiver submission for testing whole blood sample types.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Device: Sofia 2 Lyme FIA testingArm 1 is a multi-site, single visit, prospective clinical study where subjects will be enrolled based on a physician's assessment of current Lyme specific symptoms from recent contact with a tick. |
| Arm 2 | – | Device: Sofia 2 Lyme FIA testingArm 2 will consist of subjects selected from a pool of patients that were previously determined to have Lyme disease either by the presence of the diagnostic rash (erythema migrans) or through laboratory findings and physician diagnosis based on patient symptoms. In this Arm the site may recruit by contacting subjects previously diagnosed with Lyme disease no longer than 16 months post diagnosis and no earlier than 1 week post diagnosis. |
| Arm 3 | – | Device: Sofia 2 Lyme FIA testingArm 3 will consist of subjects selected from a pool of patients that were previously determined to have Lyme disease either by the presence of the diagnostic rash (erythema migrans) or through laboratory findings and physician diagnosis based on patient symptoms. In this Arm the site may recruit by contacting subjects previously diagnosed with Lyme disease between 17 months and 50 months post diagnosis. For the subject to be enrolled, a physician must have diagnosed the subject to have Lyme disease based on clinical symptoms. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Known or suspected exposure or tick-bite from an endemic area prior to onset of symptoms
Key inclusion criteria (24 listed)
- Arm 1 - Prospective symptomatic subjects, must have had a known or suspected exposure or tick-bite from an endemic area prior to onset of symptoms, and be currently exhibiting the following:
- The physician determines that the subject has an expanding erythema migrans (EM) lesion or "bulls-eye rash" with evidence of clearing in the center and has requested 2 tier serological testing or prescribed a ≥10 day course of antibiotics such as doxycycline in subjects > 8 years old or amoxicillin, cefuroxime or doxycycline in subjects ≤8 years of age:
- Or
- The physician must observe current symptoms, including:
- fatigue
Key exclusion criteria (1 listed)
- Unable to understand and consent to participation; for minors this includes parent or legal guardian.
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 |
|---|---|---|
| Sofia 2 Lyme FIA testingIVD testing of whole blood or serum/plasma to aid in the detection of anti-B. burgdorferi IgG / IgM antibody | Device | Arm 1, Arm 2, Arm 3 |
Primary outcome
Detection of anti-B. burgdorferi IgG / IgM antibody
Time frame: 15 minutes
Accurate detection of presence or absence of anti-B. burgdorferi IgG / IgM antibody
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 20 Mar 2018.
- Individual participant dataSharing planned: No. There is no plan or intention to share participant data with others.
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.
Tom Clement study director
Quidel Corporation
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans), run by Quidel Corporation at 11 sites in United States.
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 24 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 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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?
Detection of anti-B. burgdorferi IgG / IgM antibody (time frame: 15 minutes). 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 20 Mar 2018.