A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seronegative Chronic Lyme Disease
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lyme Disease
Intervention: ceftriaxone (Drug); doxycycline (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
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)
persistent infection by B. burgdorferi; 2) damage caused by the original infectious process;
or 3) the presence of coinfection with another organism transmitted by Ixodes ticks. The
purpose of this study is to determine the safety and effectiveness, in seronegative patients,
of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease (CLD).
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seronegative Chronic Lyme Disease
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Detailed description:
Sixty-six 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
You may be eligible for this study if you:
- Are at least 18 years of age.
- Are seronegative 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, beginning 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 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 or 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.
- Have tested seropositive by Western Blot (these patients may be offered enrollment in
seropositive study).
Locations and Contacts
Mark Klempner, Boston, Massachusetts 02111, United States
Additional Information
Ending date: November 2005
Last updated: November 11, 2005
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