Clinical trial NCT00001101: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lyme Disease
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mark Klempner
state: Massachusetts
Study officials:
References:
citation: Klempner MS, Hu LT, Evans J, Schmid CH, Johnson GM, Trevino RP, Norton D, Levy L, Wall D, McCall J, Kosinski M, Weinstein A. Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. N Engl J Med. 2001 Jul 12;345(2):85-92. doi: 10.1056/NEJM200107123450202.
citation: Klempner MS, Schmid CH, Hu L, Steere AC, Johnson G, McCloud B, Noring R, Weinstein A. Intralaboratory reliability of serologic and urine testing for Lyme disease. Am J Med. 2001 Feb 15;110(3):217-9. doi: 10.1016/s0002-9343(00)00701-4. No abstract available.
citation: Perides G, Charness ME, Tanner LM, Peter O, Satz N, Steere AC, Klempner MS. Matrix metalloproteinases in the cerebrospinal fluid of patients with Lyme neuroborreliosis. J Infect Dis. 1998 Feb;177(2):401-8. doi: 10.1086/514198.
citation: Klempner M, Hu L, Johnson G. Severe physical disability and other characteristics in patients with post treatment chronic Lyme disease. VIII International Conference on Lyme Borreliosis and other Emerging Tick-Borne Diseases, Munich, Germany June 20-24, 1999.