The two-tier Lyme disease criteria introduced in 1994 proved to be a poorly sensitive test in actual practice. Studies have shown that only one-third of all well-characterized cases of Lyme disease are positive by the two-tier Lyme disease test. Over the past few years, an increasing number of tests have been introduced to improve the reliability of serologic tests for tick-borne illnesses. These tests include PCR, t-cell, and antigen detection tests.
Dr. C & Associates is seeking volunteers for a clinical trial to validate a new Lyme disease test.
Dr. C & Associates, located in the Hudson Valley New York area, is uniquely positioned in a region where Lyme disease is endemic, enabling the practice to participate in much-needed clinical research projects, including the validation of newly developed Lyme disease tests.
Since 1987, Dr. C has been evaluating and treating thousands of individuals with tick-borne illnesses. He has served as a clinical investigator for numerous clinical trials and has participated in national and international conferences.
Having a significant number of study participants is important when conducting randomized, double-blind clinical trials, says Dr. C. The National Institute of Health (NIH) has conducted four trials over the past decade. In total, those studies included a mere 200Â Lyme disease patients.
“Run the numbers. With 300,000 people diagnosed with Lyme disease each year, the NIH, over the past decade, has only studied 200 patients. Treatment decisions are being made based on clinical trials that involve a minuscule number of subjects.” The IDSA treatment guidelines, which dictate the treatment of hundreds of thousands of patients, are based on the results of those four NIH trials, which included a total of 200 patients, he adds.
Dr. C is currently involved in a project to validate the effectiveness of a newly developed Lyme disease test. It is not a treatment study, he points out. But volunteers are still needed.
“The more volunteers with newly diagnosed Lyme disease, the more we can help to find a new test,” says Dr. C, director of the tick-borne validation program. “Because of the increase in Lyme disease cases, we have had a strong summer with volunteers enrolling but we could still use more participants.”
Dr. C & Associates welcomes volunteers, who are newly diagnosed with Lyme disease, as well as those who have never had the disease.
If interested in participating in the study, please call 914-666-4665.
Posted by poppy (Member # 5355) on :
Newly diagnosed means anyone at any stage, right? You could just have been diagnosed but have had it a long time. I wonder if the diagnosis can be clinical or means prior testing has been done and is positive. Hopefully this study does not require a positive test per CDC to enter.
My guess is that people who just were bitten and have already been diagnosed probably won't learn about the study because they will not get as far as lyme docs, will be treated by some GP. Early catches are not the problem. And these days, finding people who never had lyme is more tricky, because they may not know it, might have an immune system holding it down.
Good for them for initiating the study. Hope it goes well.