chronic lyme study

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Description:

Lyme disease is the most common tick-borne infection in the United States. It is

caused by Borrelia burgdorferi, a spirochete that is transmitted to humans by

ticks. The natural carriers of the tick are rodents, especially the white footed

mouse and the deer. The majority of patients with Lyme Disease have early

symptoms, such as a bulls eye rash, fever, headache general flu like symptoms.

These patients are easily treated with antibiotics. However, some patients

develop Chronic Lyme Disease, especially Lyme arthritis or neurological

symptoms, which may be more difficult to diagnose and treat.

Another form of Chronic Lyme Disease occurs in patients who have been treated

with antibiotics, often at an early stage, but who do not fully recover (Post

Treatment Chronic Lyme Disease). These patients complain of joint and muscle

pains, (without objective findings of arthritis) difficulty with memory and

concentration, and associated fatigue, all of which have affected their quality

of life. The cause of this clinical condition remains uncertain but

possibilities include: chronic active infection by the spirochete that has

escaped eradication by conventional antibiotic treatment; residual damage

(especially to the central nervous system ) caused by the original illness; a

post infectious immunological disorder; a possible infection with another

organism which the tick may have also carried. (We know the tick does carry

other bacteria such as human granulocytic ehrlichiosis or Babesia microti.)

Objectives:

There are a number of objectives to this study:

1.. To determine whether an intensive course of antibiotic therapy results in

short-term and long-term improvement in patients with Post Treatment Chronic

Lyme Disease(CLD).

2.. To determine whether evidence of persistent infection with Borrelia

burgdorferi can be found in patients with CLD.

3.. To test for evidence of co-infection with microorganisms such as Babesia

and Ehrlicia in these patients with CLD.

4.. To identify new diagnostic markers in serum and/or spinal fluid for

patients with CLD.

5.. To determine whether specific clinical, neurocognitive or laboratory tests

improve in patients who receive antibiotics compared to patients who receive

placebo.

6.. To determine whether specific clinical or laboratory pre-treatment results

predict a positive response to therapy.

Study Design:

There are 2 important aspects of the treatment study:

1.. The participants will be randomly placed in two groups. One receiving

medication and one receiving no medication. No one will know which group the

participant was in until the end of the study. Both will receive that identical

care and attention.

2.. Those receiving medication will receive antibiotics for 3 months. (1 month

intravenous and 2 months oral). The participants who will not receive medication

will get a very dilute vitamin.

REMEMBER, WE DO NOT CURRENTLY HAVE ANY EVIDENCE IF OR HOW ANTIBIOTICS AFFECT

PTCLD.

The symptoms of PTCLD are subjective with few or no physical or laboratory

findings. The assessments for improvement in this study are also subjective,

including the simple " are you feeling better? " . Thus, in order to determine if

antibiotics are truly effective in the short and long run, it is necessary to

have a group of patients that receives no medication and that neither the

patient nor the physician-investigator or staff know who is receiving what. This

is to avoid any bias on the part of the staff or participants.

All patients will have already been treated with at least one course of

antibiotics without success.

Questions:

For questions concerning details about this study, please contact

in Boston at (617)-636-4893 or Delona Norton at (914)-594-4530 in Westchester

County, NY or e-mail to gary.johnson@... or delona_norton@...