Lyme DiseaseALSIBDTNCT02741609
A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease
A study testing Borrelia Diagnostic Test in people with Lyme Disease, run by Advanced Laboratory Services, Inc. at 16 sites in United States.
Trial summary
This study will evaluate Advanced Laboratory Services Borrelia diagnostic test by culturing Borrelia spirochetes from human serum in subjects with early or late Lyme disease. This is an 8 month study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lyme Disease
- What is being tested?
- Borrelia Diagnostic Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 16 sitesUnited States
- Study dates
- Apr 2016to Jan 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must provide written informed consent prior to the conduct of any study-related procedures.
- Male or female subjects who are at least 18 years of age.
- Subjects are suspected to have early Lyme disease based on the following criteria: Signs, symptoms and clinical history consistent with early-stage Lyme disease. Subjects must have a medical practitioner-diagnosed erythema migrans (EM) rash and should have systemic symptoms indicative of disseminated infection. Symptoms may include fever, headache, fatigue, myalgias, arthralgias, and stiff neck. Paired acute and convalescent titers will be drawn (first draw at time of initial visit and second draw 4 weeks later) or,
- Subjects are suspected to have late Lyme disease based on the following criteria: Signs, symptoms and clinical history consistent with late stage Lyme disease, including but not limited to disseminated rash, arthritis, meningitis, facial palsy, or carditis.
- Subjects must be willing and have the ability to safely have the required quantity of blood drawn for the study at the discretion of the investigator.
- Subjects must have blood samples freshly collected (no supplemental frozen samples) and the samples must reach ALSI's laboratory on a weekday and within 24 hours of being drawn.
- ---
Who cannot join
- Early Lyme disease: Subjects without an EM rash or do not have symptoms recognized as being associated with Lyme disease.
- Exposure to antibiotics of any type during the 6 weeks prior to the initial blood sample collection.
- Immune deficiency significant enough to render serological tests less reliable.
- The subject is unwilling or unable to safely have the required quantity of blood drawn for this study.
- Subjects who are not able to understand all of the requirements of the study or unable to give informed consent and/or comply with all aspects of the evaluation.
- Subjects that have any other condition or situation which, in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study.
- Subjects that have undergone testing for Lyme disease within the past year.
- Subjects that have a prior diagnosis of Lyme disease.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Virginia Center for Health & Wellness
Aldie, Virginia, 20105
Lyme Center of New England
Cumberland, Rhode Island, 02864
Dr. Marina Makous
Exton, Pennsylvania, 19341
Delaware Integrative Medicine
Georgetown, Delaware, 19947
Detweiler Family Medicine & Associates, PC
Lansdale, Pennsylvania, 19446
Rockbridge Traditional Medicine
Lexington, Virginia, 24450
Suburban Research Associates
Media, Pennsylvania, 19063
Mid Hudson Medical Research, PLLC
New Windsor, New York, 12553
Andrs Wellness Consulting
Petersburg, Virginia, 23803
The Miriam Hospital of Infectious Diseases
Providence, Rhode Island, 02906
Dr. Steven Bock, MD
Rhinebeck, New York, 12572
Penobscot Bay Medical Center
Rockport, Maine, 04956
Birch Tree Healing Arts
Saint Paul, Minnesota, 55114
Cumberland Valley Parochial Medical Clinic
Shippensburg, Pennsylvania, 17257
Infectious Disease/The Research Institute
Springfield, Massachusetts, 01105
Cardinal Internal Medicine
Woodbridge, Virginia, 22192
About this study
This study will evaluate Advanced Laboratory Services Borrelia diagnostic test by culturing Borrelia spirochetes from human serum in subjects with early or late Lyme disease.
This is an 8 month study. Subjects entering the study will have two blood samples collected one month apart if they have early Lyme disease and one blood sample collected if they have late Lyme disease. Subjects who sign an IRB-approved consent form and meet the inclusion and exclusion criteria will be entered into the study. Subjects will be assigned a subject number upon entry and this number will be retained throughout the study.
- Conditions
- Lyme Disease
- Being tested
- Borrelia Diagnostic Test
- Keywords
- Borrelia, spirochetes, culture, immunostaining
- Medical subject headings
- Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Borrelia Diagnostic TestDevice
The ALSI BDT is a high-yield in vitro cultivation method for Borrelia burgdorferi from venous whole blood samples.
| Study group | Role | What they receive |
|---|---|---|
| Early/Late Stage Lyme disease | Experimental | Have early Lyme disease based on the following criteria: Signs, symptoms and clinical history consistent with early stage Lyme disease. Subjects must have a physician-diagnosed erythema migrans (EM) rash and should have systemic symptoms indicative of disseminated infection. Symptoms may include fever, headache, fatigue, myalgias, arthralgias, and stiff neck. Paired acute and convalescent titers will be drawn (first draw at time of initial visit and second draw 4 weeks later). Have late Lyme disease based on the following criteria: Signs, symptoms and clinical history consistent with late stage Lyme disease, including but not limited to disseminated rash, arthritis, meningitis, facial palsy, or carditis. Qualified subjects will be administered the Borrelia Diagnostic Test. Receives: Device: Borrelia Diagnostic Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the Advanced Laboratory Services, Inc. (ALSI) Borrelia Diagnostic Test (BDT) culture, for positive and negative predictive value, as compared to conventional microbiological methods.
Measured: Baseline to 16 weeks
Secondary outcomes (2)
Diagnostic accuracy of ALSI culture for early-onset presentation of Lyme disease, as measured by positive and negative predictive value.
Measured: Baseline to 16 weeks
Diagnostic accuracy of ALSI culture for late-onset presentation of Lyme disease, as measured by positive and negative predictive value.
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017
- Study completionJan 2018
Why it stopped: Sponsor lack of funding
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Laboratory Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jasbir Arora, PhD, Principal investigator, Advanced Laboratory Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741609
- Sponsor's protocol ID
- IR-12
- Acronym
- ALSIBDT
- Status last verified
- Jan 2018
- First submitted
- 6 Apr 2016
- Last updated
- 17 Jan 2018
- 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 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease
- ClinicalTrials.gov ID
- NCT02741609
- Acronym / sponsor ID
- ALSIBDT / IR-12
- Conditions
- Lyme Disease
- Keywords
- Borrelia, spirochetes, culture, immunostaining
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor lack of funding
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Advanced Laboratory Services, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 18 Apr 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.
This study will evaluate Advanced Laboratory Services Borrelia diagnostic test by culturing Borrelia spirochetes from human serum in subjects with early or late Lyme disease.
This is an 8 month study. Subjects entering the study will have two blood samples collected one month apart if they have early Lyme disease and one blood sample collected if they have late Lyme disease. Subjects who sign an IRB-approved consent form and meet the inclusion and exclusion criteria will be entered into the study. Subjects will be assigned a subject number upon entry and this number will be retained throughout the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early/Late Stage Lyme disease | Experimental | Device: Borrelia Diagnostic TestHave early Lyme disease based on the following criteria: Signs, symptoms and clinical history consistent with early stage Lyme disease. Subjects must have a physician-diagnosed erythema migrans (EM) rash and should have systemic symptoms indicative of disseminated infection. Symptoms may include fever, headache, fatigue, myalgias, arthralgias, and stiff neck. Paired acute and convalescent titers will be drawn (first draw at time of initial visit and second draw 4 weeks later). Have late Lyme disease based on the following criteria: Signs, symptoms and clinical history consistent with late stage Lyme disease, including but not limited to disseminated rash, arthritis, meningitis, facial palsy, or carditis. Qualified subjects will be administered the Borrelia Diagnostic Test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must provide written informed consent prior to the conduct of any study-related procedures.
- Male or female subjects who are at least 18 years of age.
- Subjects are suspected to have early Lyme disease based on the following criteria: Signs, symptoms and clinical history consistent with early-stage Lyme disease. Subjects must have a medical practitioner-diagnosed erythema migrans (EM) rash and should have systemic symptoms indicative of disseminated infection. Symptoms may include fever, headache, fatigue, myalgias, arthralgias, and stiff neck. Paired acute and convalescent titers will be drawn (first draw at time of initial visit and second draw 4 weeks later) or,
- Subjects are suspected to have late Lyme disease based on the following criteria: Signs, symptoms and clinical history consistent with late stage Lyme disease, including but not limited to disseminated rash, arthritis, meningitis, facial palsy, or carditis.
- Subjects must be willing and have the ability to safely have the required quantity of blood drawn for the study at the discretion of the investigator.
Key exclusion criteria (8 listed)
- Early Lyme disease: Subjects without an EM rash or do not have symptoms recognized as being associated with Lyme disease.
- Exposure to antibiotics of any type during the 6 weeks prior to the initial blood sample collection.
- Immune deficiency significant enough to render serological tests less reliable.
- The subject is unwilling or unable to safely have the required quantity of blood drawn for this study.
- Subjects who are not able to understand all of the requirements of the study or unable to give informed consent and/or comply with all aspects of the evaluation.
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 |
|---|---|---|
| Borrelia Diagnostic TestThe ALSI BDT is a high-yield in vitro cultivation method for Borrelia burgdorferi from venous whole blood samples. | Device | Early/Late Stage Lyme disease |
Primary outcome
Diagnostic accuracy of the Advanced Laboratory Services, Inc. (ALSI) Borrelia Diagnostic Test (BDT) culture, for positive and negative predictive value, as compared to conventional microbiological methods.
Time frame: Baseline to 16 weeks
2 secondary outcomes
Diagnostic accuracy of ALSI culture for early-onset presentation of Lyme disease, as measured by positive and negative predictive value.
Time frame: Baseline to 16 weeks
Diagnostic accuracy of ALSI culture for late-onset presentation of Lyme disease, as measured by positive and negative predictive value.
Time frame: Baseline to 16 weeks
Results and safety
The study was stopped early (reason given: Sponsor lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- 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.
Jasbir Arora, PhD principal investigator
Advanced Laboratory Services
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Borrelia Diagnostic Test in people with Lyme Disease, run by Advanced Laboratory Services, Inc. at 16 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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 was stopped early (reason given: Sponsor lack of funding). 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?
Diagnostic accuracy of the Advanced Laboratory Services, Inc. (ALSI) Borrelia Diagnostic Test (BDT) culture, for positive and negative predictive value, as compared to conventional microbiological methods. (time frame: Baseline to 16 weeks). 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 17 Jan 2018.