Lyme disease is the most common tick-borne disease in the United States. It is caused by the
spirochete Borrelia burgdorferi. It may exist in a chronic form and be the result of: 1)
active infection by B. burgdorferi; 2) damage caused by the original infectious process; or
3) the presence of co-infection with another organism transmitted by Ixodes ticks. The
purpose of this study is to determine the safety and effectiveness, for seropositive
patients, of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease
One hundred ninety-four (194) patients will be enrolled in this study. Each patient will be
assigned to one of two groups and will be randomly selected to receive either antibiotic
therapy or placebo; but, the assignment of medication will not be made known to the patient
or administering doctor. Antibiotic or placebo will be given intravenously (IV) for 30
consecutive days and then orally for the next 60 consecutive days.
You may be eligible for this study if you:
- Are 18 years of age or older.
- Are seropositive for antibodies against B. burgdorferi antigens by Western Blot at
- Have documented history of acute Lyme disease.
- Have had a rash (erythema migrans) that resembles a bullseye. This skin aberration
usually occurs after a tick bite in late spring, summer or early fall and is
sometimes accompanied by fatigue, fever, headache, mild stiff neck, arthralgia or
- Have had one or more clinical features typical of Lyme disease acquired in the United
States (see technical summary).
- Have had one or more of the following symptoms and conditions that have persisted for
at least 6 months (but less than 12 years) and are not attributable to another cause
or condition: a) widespread musculoskeletal pain and fatigue that began coincident
with or within 6 months following initial infection with B. burgdorferi. b) certain
neurologic symptoms including memory impairment and nerve pain within 6 months
following initial infection with B. burgdorferi.
- Have had a physician-documented history of prior antibiotic treatment with a
currently recommended antibiotic regimen.
You will not be eligible for this study if you:
- Have previously enrolled in this study.
- Are pregnant, lactating, or unable to use birth control measures during the treatment
period of this study.
- Are taking chronic medication that could interfere with evaluation of symptoms.
- Are taking or have taken various medications that could interfere with the evaluation
of symptoms (see technical summary).
- Are hypersensitive to ceftriaxone or doxycycline.
- Have active inflammatory synovitis.
- Have another disease that could account for symptoms of acute Lyme disease.
- Have another serious disease or an active infection.
- Are unable to tolerate an IV.
- Have tested positive for Borrelia DNA in plasma or cerebrospinal fluid at the time of
initial evaluation for study.