Dr. Cameron's studies

Lyme Disease Retreatment Trial      Design        FAQ        Key points Surveillance Database VOLT - Validation of Lyme Disease

Design Lyme Disease Retreatment Trial Enrollment completed - results presented at latest international meeting of ILADS and LDA, pending publication.

The aim of this study is to determine the benefits of treating recurrent Lyme diseaese with antibiotics. Call 914-666-4665.

The Lyme Disease Retreatment Study is designed to evaluate the safety and efficacy of oral antibiotics for retreatment of Lyme disease. This clinical trial evaluates a previous clinical trial showing that retreatment with antibiotics was not effective.

Design:

The study will randomize 108 Lyme disease patients with positive blood tests and 108 Lyme disease patients with negative blood tests to either amoxicillin or placebo. Patients will be treated for up to 3 months.

Target Group of Patients:

• 18 years or older
• Lyme disease symptomatology
• Patients previously successfully treated

Medications:

• Medications provided at no cost for duration of study
• Treatment for at least 3 months:
• All patients will be treated up to 3 months
• Patients are seen at 4 week intervals for 3 visits and then every 6 months

Data Collection:

• 2 simple data forms: Review of symptoms and Patient Impact Form
• Completion time ~20 min for enrollment visit, ~10 min for follow-up visits

Regulatory Requirements:

• Approval by Western IRB

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FAQ Lyme Disease Retreatment Trial

What is the Retreatment Study?

The Retreatment study of Lyme disease is a clinical trial designed to see how the drug amoxicillin compares with placebo in resolving recurrent Lyme disease in patients initially successfully treated.

Why should I participate in a retreatment study?

If retreatment is found to be effective, you’ll benefit significantly from retreatment. Two-thirds will receive amoxicillin at the start of the study and the remaining third will be treated after 3 months if they remain ill. More importantly, you’ll help contribute to a better understanding of Lyme disease and get to meet new people.

Who is eligible to participate in the Retreatment Trial?

The office expects to enroll 216 men and women over the age of 18. These volunteers must have been successfully treated in the past. Volunteers are not eligible to participate in the trial if they are allergic to amoxicillin or have failed amoxicillin in the past

Who is Lyme disease research so difficult

Lyme disease seems to be an inherently difficult disease to research. Lyme disease outcome is so variable between different people that there don't seem to be a treatment protocol that is effective for all chronic Lyme disease. Lyme disease is also variable within one person that makes trying to assess the effects of possible treatments difficult.

Why a double-blind placebo-controlled clinical trial?

The researcher and patient are not aware of the study assignment to avoid any unconscious evaluation that the treatment is better than placebo. The placebo is a phenomenum in which a patient feels better when being treated in a supportive research setting even if not receiving the study medication. The double blind trial is designed to prevent these effects.

Why are individuals with previous success the only people eligible for this study?

Chronic Lyme disease can take months or years to resolve. Some patients have significant response to 1 to 3 months of therapy. Because the treatment trial is limited to 3 months of therapy, they are the population most likely to benefit from 3 months of therapy.

Why does the study not include treatment failures and persistent Lyme disease?

Treatment failures and persistent Lyme disease exhibit only a slow improvement of function that is hard to quantify. For these reasons, we see that recurrence is more easily studied because it is easier to design a well-formed study. It is easy to form a well agreed upon definition of a recurrence. This leads to criteria for assessing the treatment such as: number of recurrences in a given time period (typically one-two years), the time to first recurrence after beginning treatment or the time between recurrences.

Why do only two of three study participants receive the tests being studied?

Two-thirds will benefit immediately if retreatment is found to be effective. The third given the placebo will be offered treatment at 3 months if they remain ill. By comparing the success of retreatment of Lyme disease in the intervention and control groups, the researchers will be able to determine the potential benefit of the treatment under study.

Why is LymeProject testing retreatment when retreatment is commonplace for chronic Lyme disease?

The value of retreatment has been limited to observational naturalistic studies. A randomized double blind placebo design is needed to prove efficacy of retreatment in order to change treatment guidelines.

Why not study coinfections including Babesia and Ehrlichia?

Babesia and Ehrlichia will be assessed if warranted by clinical judgment. The diagnostic criteria for these conditions needs to better established before designing a clinical trial.

Who will get which drug?

Two out of three participants in LDR will be randomized to amoxicillin and one out of three the placebo (an inactive pill that looks like amoxicillin). Neither the participant nor her physician will know which pill she is receiving. This “double-blind” design allows the researchers to directly compare the true benefits and side effects of each drug without the influence of other factors.

Are participants required to have any medical exams? Who will pay for these exams?

Participants are required to have a history, physical exam, and blood tests. These tests will be repeated as needed at intervals during the trial. Physicians’ fees and the costs of medical tests will be charged to the participant in the same fashion as if she were not part of the trial; however, the costs for these tests generally are covered by insurance. Every effort is made to contain the costs specifically associated with participation in this trial, and financial assistance is available for some patients.

How often will the tests be conducted?

Both the intervention and placebo group will be assessed at the initial visit and once every month for the next 3 months, except for the sickness impact profile, which will be performed only twice—during the initial visit and during the third month. The researchers will be in contact with the participants for at least one year from the time they enter the study. Participation is voluntary and participants may withdraw from the study at any time.

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Key points Lyme Disease Retreatment Trial

• The Study of retreatment of Lyme disease, known as LDRS, is the largest clinical trial in chronic Lyme disease in the U.S. ever undertaken.
• LDRS is also the first trial randomized double blind placebo controlled study of an oral antibiotic for retreatment of Lyme disease
• LDRS is the first oral antibiotic clinical trial enrolling seronegative chronic Lyme disease patients as a test of clinical judgment.
• 218 Lyme disease patient relapsing after initial success will participate in LDRS.
• The retreatment study will be situated in a primary care setting in a hyperendemic area for Lyme disease in the North Eastern United States.
• People of all ages over 18 and ethnic groups are encouraged to participate in LDRS.
• Amoxicillin is prescribed at higher doses than previously studies (3000 mg. vs. 2000 mg.) to increase blood levels of amoxicillin rather then using Probenecid
• The trial is limited to retreatment of patients previously successfully treated because patients failing initial therapy are less likely to respond to within the 3 months treatment protocol.
• Any antibiotic including the study drug, Amoxicillin, have known side effects. Any person interested in participating in the trial will be fully informed of the benefits and potential risks of these drugs.
• The most common side effects of amoxicillin are stomach upset, diarrhea, and in women, yeast infections. Treatments to eliminate or minimize side effects are available including Acidophilus.
• Serious side effects are known to occur in patients taking amoxicillin, including acute allergic reactions and colitis.
• The study is a single site in New York, limits the study to patients available for followup (usually within a radius of 200 miles).
• Lyme disease patients in the United States who are interested in participating in LDRS can call the office at 1-914-666-4665.

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Lyme Disease Surveillance Database

The long term collection and analysis of Lyme disease data through a surveillance database offers the opportunity to identify new patterns in Lyme disease management.

Long term collection and analysis of Lyme disease data through a surveillance database offers the opportunity to identify new patterns in Lyme disease management. The Lyme disease surveillance launched in June 1997 examines all Lyme disease patients evaluated in a primary care setting situated in a hyperendemic area of the Northeast United States.

There are three important reasons for maintaining a primary care setting Lyme disease surveillance database:

1. Education: The data collected and maintained in the surveillance database serves as a valuable resource for researchers interested in the diagnosis and treatment of Lyme disease.

2. Research: Statistical reports of surveillance data enable physicians who treat Lyme disease patients to evaluate the success of specific antibiotics treatment. Results have been presented through periodic reports at local and International Lyme disease meetings. Results have been used to model the current retreatment clinical trials.

3. Public Health: The registry results have been used to increase awareness of outcome of persistent and recurrent chronic Lyme disease and evaluate public policy and education. Be a service to local areas for planning of health care services and investigation of persistent, recurrent, and refractory Lyme disease.

The LymeProject Surveillance database is an ongoing prospective study of the natural and treated histories of Lyme disease conducted in a primary care office located in Mt. Kisco, New York, U.S.A.. From June 1997 through April 2002, 2500 adolescents and adults were observed. Results have been presented through periodic reports at local and International Lyme disease meetings. Results have been used to model the current retreatment clinical trials.

What is the Lyme disease Surveillance Database?

The Surveillance Data base is a patient registry of all patients evaluated in primary care setting situated in a hyperendemic area of the Northeast United States with Lyme disease. We developed and maintain the registry database and present periodic reports at local and International Lyme disease meetings. The registry results have been used to increase clinician awareness of outcome of persistent and recurrent chronic Lyme disease and to model our retreatment clinical trials.

How many patients are represented in the surveillance database?

The database contains over 2000 patients with Lyme disease, including those that are persistent and recurrent. As the database grows to include all consecutively evaluated patients from the practice, the number of chronic Lyme disease conditions in the database will grow.

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VOLT - Validation of Lyme Disease Retreatment

This is a retrospective study of previously treated Lyme disease patients using a case-control technique to validate the treatment guidelines adopted by the International Lyme and Associated Diseases Society (ILADS.

Presented - Cameron DJ. VOLT – Validation of Lyme treatment. Presented to the International Lyme Disease and Associated Disorders Society (ILADS). Philadelphia, Pennyslvania, 2003.

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