The objective of this proposal is to determine, in a double-blinded prospective trial, whether the short and long term outcome in patients with Lyme disease and erythema migrans can be altered by varying the duration of standard oral antimicrobial therapy, or by supplementing oral therapy with one 2 gram dose of intravenous ceftriaxone given at the beginning of treatment. In addition, by prospectively studying such patients over 30 months via neuro-psychiatric testing, audiometry, and careful physical examination, we hope to determine the true incidence of rheumatologic and neuro-psychiatric complications of treated Lyme disease, better define the """"""""post-Lyme syndrome,"""""""" and determine the risk factors (e.g. complicated vs. uncomplicated EM, multiple EM lesions, history of psychiatric illness) for these entities. Much of what we know about Lyme disease is based upon non-randomized and/or non-blinded therapeutic trials with relatively few patients and brief periods of follow-up. In particular, new trials are needed that are prospective and double-blinded, and compare different durations of anti-microbial therapy. We will enroll 150 patients over 2 years, and randomize them to receive either 1) one 2 gr IV dose of ceftriaxone plus doxycycline 100 mg po BID x 10 days, 2) doxycycline 100 mg po BID x 20 days, plus placebo IV treatment, or 3) doxycycline 100 mg po BID x 10 days, plus placebo IV treatment. By following these patients over 30 months we hope to define better the sequelae of Lyme disease, their risk factors, and patient response to therapy. Our center, experienced in enrolling patients for prospective trials in EM, and located in a county with one of the highest incidences of Lyme disease in the United States (1), is uniquely situated to accomplish these goals.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Research Project (R01)
Project #
5R01AR041508-03
Application #
3161969
Study Section
Arthritis and Musculoskeletal and Skin Diseases Special Grants Review Committee (AMS)
Project Start
1991-09-30
Project End
1995-08-31
Budget Start
1993-09-10
Budget End
1994-08-31
Support Year
3
Fiscal Year
1993
Total Cost
Indirect Cost
Name
New York Medical College
Department
Type
Schools of Medicine
DUNS #
City
Valhalla
State
NY
Country
United States
Zip Code
10595
Wormser, Gary P; Ramanathan, Roshan; Nowakowski, John et al. (2003) Duration of antibiotic therapy for early Lyme disease. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 138:697-704
Pavia, C S; Wormser, G P; Bittker, S et al. (2000) An indirect hemagglutination antibody test to detect antibodies to Borrelia burgdorferi in patients with Lyme disease. J Microbiol Methods 40:163-73
Nowakowski, J; McKenna, D; Nadelman, R B et al. (2000) Failure of treatment with cephalexin for Lyme disease. Arch Fam Med 9:563-7
Strle, F; Nadelman, R B; Cimperman, J et al. (1999) Comparison of culture-confirmed erythema migrans caused by Borrelia burgdorferi sensu stricto in New York State and by Borrelia afzelii in Slovenia. Ann Intern Med 130:32-6
Wormser, G P; Liveris, D; Nowakowski, J et al. (1999) Association of specific subtypes of Borrelia burgdorferi with hematogenous dissemination in early Lyme disease. J Infect Dis 180:720-5
Liveris, D; Varde, S; Iyer, R et al. (1999) Genetic diversity of Borrelia burgdorferi in lyme disease patients as determined by culture versus direct PCR with clinical specimens. J Clin Microbiol 37:565-9
Wormser, G P; Nowakowski, J; Nadelman, R B et al. (1998) Improving the yield of blood cultures for patients with early Lyme disease. J Clin Microbiol 36:296-8
Nowakowski, J; Schwartz, I; Nadelman, R B et al. (1997) Culture-confirmed infection and reinfection with Borrelia burgdorferi. Ann Intern Med 127:130-2
Nadelman, R B; Horowitz, H W; Hsieh, T C et al. (1997) Simultaneous human granulocytic ehrlichiosis and Lyme borreliosis. N Engl J Med 337:27-30
Rikihisa, Y; Zhi, N; Wormser, G P et al. (1997) Ultrastructural and antigenic characterization of a granulocytic ehrlichiosis agent directly isolated and stably cultivated from a patient in New York state. J Infect Dis 175:210-3

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