A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of C… (NCT00001101) | Clinical Trial Compass
CompletedPhase 3
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seropositive Chronic Lyme Disease
United States194 participants
Plain-language summary
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 (CLD).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
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 enrollment.
* 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 myalgia.
* 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.
Exclusion Criteria:
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 …
Trial details
NCT IDNCT00001101
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)