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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

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ClinicalTrials.gov Identifier: NCT00001101
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : August 27, 2010
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

November 2, 1999
August 31, 2001
August 27, 2010
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March 2001   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00001101 on ClinicalTrials.gov Archive Site
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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
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
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).
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Lyme Disease
  • Drug: ceftriaxone
  • Drug: doxycycline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
194
Same as current
March 2001
March 2001   (Final data collection date for primary outcome measure)

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 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00001101
DMID 97-002
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National Institute of Allergy and Infectious Diseases (NIAID)
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National Institute of Allergy and Infectious Diseases (NIAID)
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP