Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
---|---|
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001101 |
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).
Condition | Intervention | Phase |
---|---|---|
Lyme Disease |
Drug: ceftriaxone Drug: doxycycline |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 Seropositive Chronic Lyme Disease |
Estimated Enrollment: | 194 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
You may be eligible for this study if you:
Exclusion Criteria:
You will not be eligible for this study if you:
Study ID Numbers: | DMID 97-002 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00001101 |
Health Authority: | United States: Federal Government |
Bacterial Infections Borrelia Infections Borreliosis Lyme Disease |
Ceftriaxone Doxycycline Tick-Borne Diseases Gram-Negative Bacterial Infections |
Antimalarials Anti-Infective Agents Anti-Bacterial Agents Antiparasitic Agents |
Antiprotozoal Agents Spirochaetales Infections Therapeutic Uses Pharmacologic Actions |