Lyme DiseaseNCT05041595
Lyme Disease Diagnostic Assay - Collection of Whole Blood
An observational study of Lyme Disease and Healthy, run by DiaSorin Inc. at 1 site in United States.
Trial summary
The primary objective is to obtain whole blood from subjects with signs and/or symptoms of early Borrelisois. Whole blood will also be obtained from subjects with suspicion of acute Borreliosis and under medical examination for Lyme disease. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lyme Disease, Healthy
- What is being tested?
- Lyme diagnostic assay
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2021to 31 Dec 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects with suspected Borreliosis including subjects with EM rash and subjects without EM rash but with signs and symptoms consistent with suspicion of acute Borreliosis and under medical examination for Lyme disease. Healthy subjects living in endemic Lyme disease area and healthy subjects living in a non-endemic Lyme disease area.
Who may be able to join
- Signs and symptoms of acute Lyme disease which include at least one of the following:
- Recent onset of fatigue
- Skin rash
- Fever
- Muscle aches
- Neck pain
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- Joint pain or lymphadenopathy
- Subgroup Borreliosis Subjects- restricted signs and symptoms of acute Lyme including EM Rash
- Under physician or medical evaluation for acute on-set of Lyme Disease presenting with EM Rash
- Detailed description of the EM rash (e.g. Itchy, painful, hot, vesicular, raised) with consent for photographic documentation is required including additional picture with ruler placing to confirming size.
- EM rash with the following attributes:
- Size > 5 cm in diameter
- Appeared 3-30 days after bite or suspected bite
- Specify Location (e.g. underarm or back of knee)
- Subjects with confirmed early localized or disseminated Lyme Borreliosis manifestation
- Signs and symptoms (e.g. Fever, Chills/Sweats, Headache, Fatigue/Tiredness, Myalgia/Sore muscles)
- The EM rash has been present <42 days
- Clinical diagnosis of Lyme disease is suspected by the practitioner
- Ability to provide the minimum sample volume required
- Apparently healthy subjects with no present fever, chills, headache, fatigue, muscle and joint aches, and swollen lymph nodes, e.g. flu-like symptoms.
- Ability to provide the minimum sample volume required.
Who cannot join
- Subjects unable to provide informed consent.
- Subjects without clinical information and/or not meeting inclusion criteria.
- Subjects having started antibiotic treatment > 5 days before inclusion.
- Healthy Subjects
- ● Subjects unable to provide informed consent
- Subjects without clinical information and/or not meeting inclusion criteria
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- Subjects with a recent diagnosis of Lyme disease, Anaplasmosis, Babesiosis, or history of known embedded tick bite which may have required 'manual extraction' NOTE: a tick just found on the subject or presence of a crawling tick is not considered a 'tick bite')
- Subjects currently on antibiotic treatment.
- Uncontrolled HIV-infection, if known. This is defined as an HIV-1 viral load >40 copies/mL and/or CD4+ count <500 x 106 cells/liter in the past 12 months.
- Active syphilis or leptospirosis, if known
- Active infection with Epstein Barr Virus (mononucleosis), if known
- Active infection with Cytomegalovirus (CMV), if known
- Subjects with autoimmune diseases, either confirmed rheumatoid arthritis and/or other autoimmune disorders diagnosed according to the leading guidelines
- Current immunomodulation mediation including >7.5 mg prednisone daily, methotrexate, and/or biologicals. Medications such as hydroxychloroquine, sulfasalazine or NSAIDs are acceptable.
- Immunodeficiency, hematologic malignancies in the medical history
- Chemotherapy during the past year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collection of Whole Blood to be Used to Provide the Safety and Effectivenss of a Lyme Disease Diagnostic Assay to Support the Proposed Intended Use Statement and Product Labeling Claims.
The primary objective is to obtain whole blood from subjects with signs and/or symptoms of early Borrelisois. Whole blood will also be obtained from subjects with suspicion of acute Borreliosis and under medical examination for Lyme disease.
In addition, whole blood will be obtained from apparently healthy subjects residing in areas endemic to Lyme disease and may also inlclude apparently healthy subjects residing in areas non-endemic to Lyme disease.
Read the detailed description
Whole blood will be collected, and processed. Some blood will be transferred to additional tubes for further processing and aliquotting. Serum and plasma will be harvested and tested, at a later date, in a clinical performance study with approved and/or commercially available devices as well as an investigational Lyme assay. This study will be coordinated by the Sponsor.
- Conditions
- Lyme Disease, Healthy
- Being tested
- Lyme diagnostic assay
- Medical subject headings
- Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyme diagnostic assayDiagnostic test
Serological and immunoresponse assay
| Study group | Role | What they receive |
|---|---|---|
| Sick Cohort | Borreliosis Subjects - All comers expressing signs and symtoms consistent with suspicion of acute Borreliosis and under medical examination for Lyme disease Borreliosis subjects with an Erythema Migrans Rash (subgroup) Receives: Diagnostic Test: Lyme diagnostic assay | |
| Apparently Healthy | Apparently healthy subjects living in an area non-endemic for Lyme disease Apparently healthy subjects living in an area endemic for Lyme disease Receives: Diagnostic Test: Lyme diagnostic assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance - Sensitivity
Diagnostic Sensitivity
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Clinical Performance - Specificity
Diagnostic Specificity
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start3 May 2021
- Primary completion30 Dec 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DiaSorin Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041595
- Sponsor's protocol ID
- PROT.648.00024.A
- Status last verified
- Feb 2024
- First submitted
- 26 Aug 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Whole Blood to be Used to Provide the Safety and Effectivenss of a Lyme Disease Diagnostic Assay to Support the Proposed Intended Use Statement and Product Labeling Claims.
- ClinicalTrials.gov ID
- NCT05041595
- Acronym / sponsor ID
- PROT.648.00024.A
- Conditions
- Lyme Disease, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- DiaSorin Inc.Industry (pharma, biotech, devices)
- Study start
- 3 May 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Sep 2021 (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 primary objective is to obtain whole blood from subjects with signs and/or symptoms of early Borrelisois. Whole blood will also be obtained from subjects with suspicion of acute Borreliosis and under medical examination for Lyme disease.
In addition, whole blood will be obtained from apparently healthy subjects residing in areas endemic to Lyme disease and may also inlclude apparently healthy subjects residing in areas non-endemic to Lyme disease.
Detailed description
Whole blood will be collected, and processed. Some blood will be transferred to additional tubes for further processing and aliquotting. Serum and plasma will be harvested and tested, at a later date, in a clinical performance study with approved and/or commercially available devices as well as an investigational Lyme assay. This study will be coordinated by the Sponsor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sick Cohort | – | Diagnostic Test: Lyme diagnostic assayBorreliosis Subjects - All comers expressing signs and symtoms consistent with suspicion of acute Borreliosis and under medical examination for Lyme disease Borreliosis subjects with an Erythema Migrans Rash (subgroup) |
| Apparently Healthy | – | Diagnostic Test: Lyme diagnostic assayApparently healthy subjects living in an area non-endemic for Lyme disease Apparently healthy subjects living in an area endemic for Lyme disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with suspected Borreliosis including subjects with EM rash and subjects without EM rash but with signs and symptoms consistent with suspicion of acute Borreliosis and under medical examination for Lyme disease. Healthy subjects living in endemic Lyme disease area and healthy subjects living in a non-endemic Lyme disease area.
Key inclusion criteria (21 listed)
- Recent onset of fatigue
- Skin rash
- Fever
- Muscle aches
- Neck pain
Key exclusion criteria (16 listed)
- Subjects unable to provide informed consent.
- Subjects without clinical information and/or not meeting inclusion criteria.
- Subjects having started antibiotic treatment > 5 days before inclusion.
- Healthy Subjects
- ● Subjects unable to provide informed consent
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 |
|---|---|---|
| Lyme diagnostic assaySerological and immunoresponse assay | Diagnostic test | Apparently Healthy, Sick Cohort |
Primary outcome
Clinical Performance - Sensitivity
Time frame: Through study completion, an average of 1 year
Diagnostic Sensitivity
1 secondary outcome
Clinical Performance - Specificity
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lyme Disease and Healthy, run by DiaSorin Inc. at 1 site 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 21 inclusion and 16 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 20 Feb 2024. 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 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?
Results are not available in the source record.
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?
Clinical Performance - Sensitivity (time frame: Through study completion, an average of 1 year). 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 Feb 2024.