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

Completed · Phase 3

Conditions studied: Lyme Disease

In brief

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).

Key facts

Study ID

NCT00001101

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

194

Expected to finish

2001-03-01

Last updated by the study team

2010-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mark Klempner — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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