- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03238274
Sofia 2 Lyme FIA Whole Blood Clinical Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Fall River, Massachusetts, United States, 02721
- NECCR Primacare Research, LLC
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South Westport, Massachusetts, United States, 02790
- Main Road Family Medicine
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Minnesota
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Duluth, Minnesota, United States, 55805
- Essentia Institute of Rural Health
-
-
New York
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Endwell, New York, United States, 13760
- Regional Clinical Research
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Altoona Center for Clinical Research
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Harleysville, Pennsylvania, United States, 19438
- Harleysville Medical Associates
-
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Rhode Island
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Lincoln, Rhode Island, United States, 02865
- Lincoln Primary Care
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Providence, Rhode Island, United States, 02906
- The Miriam Hospital
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Providence, Rhode Island, United States, 02908
- Center for Medical Research, LLC
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Westerly, Rhode Island, United States, 02891
- Ocean State Primary Care
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- Marshfield Clinic Research Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- Unable to understand and consent to participation; for minors this includes parent or legal guardian.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
IVD testing of whole blood or serum/plasma to aid in the detection of anti-B.
burgdorferi IgG / IgM antibody
|
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.
|
IVD testing of whole blood or serum/plasma to aid in the detection of anti-B.
burgdorferi IgG / IgM antibody
|
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.
|
IVD testing of whole blood or serum/plasma to aid in the detection of anti-B.
burgdorferi IgG / IgM antibody
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
15 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tom Clement, Quidel Corporation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Vector Borne Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Skin Diseases, Infectious
- Skin Manifestations
- Skin Diseases, Bacterial
- Tick-Borne Diseases
- Spirochaetales Infections
- Lyme Disease
- Erythema
- Borrelia Infections
- Erythema Chronicum Migrans
Other Study ID Numbers
- CS-0267-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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