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Duration of Antibiotic Therapy for Early Lyme Disease: A Randomized, Double-Blind, Placebo-Controlled Trial

Gary P. Wormser, MD; Roshan Ramanathan, MD, MPH; John Nowakowski, MD; Donna McKenna, RN, ANP; Diane Holmgren, RN; Paul Visintainer, PhD; Rhea Dornbush, PhD; Brij Singh, MD; and Robert B. Nadelman, MD
[+] Article, Author, and Disclosure Information

From New York Medical College, Valhalla, New York.

Acknowledgments: The authors thank Eleanor Bramesco, Dominic Corbi, Susan Bittker, Denise Cooper, Charles Pavia, and Kathy O'Keefe for their assistance.

Grant Support: In part by a grant from the National Institutes of Health (RO1-AR41508) (Dr. Nadelman).

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Gary P. Wormser, MD, Division of Infectious Diseases, Room 245, Munger Pavilion, New York Medical College, Valhalla, NY 10595.

Current Author Addresses: Drs. Wormser, Nowakowski, and Nadelman, Ms. McKenna, and Ms. Holmgren: Division of Infectious Diseases, New York Medical College, Room 245, Munger Pavilion, Valhalla, NY 10595.

Dr. Ramanathan: Department of Medicine, State University of New York at Stony Brook. Health Sciences Center, T16, Room 020, Stony Brook, NY 11794.

Dr. Visintainer: New York Medical College, Learning Center, Room 213, Valhalla, NY 10595.

Dr. Dornbush: Behavioral Health, Westchester Medical Center, Room N326, Valhalla, NY 10595.

Dr. Singh: Department of Neurology, New York Medical College, Munger Pavilion, 4th Floor, Valhalla, NY 10595.

Author Contributions: Conception and design: G.P. Wormser, J. Nowakowski, B. Singh, R.B. Nadelman.

Analysis and interpretation of the data: G.P. Wormser, R. Ramanathan, J. Nowakowski, D. McKenna, P. Visintainer, R. Dornbush, R.B. Nadelman.

Drafting of the article: G.P. Wormser, R. Ramanathan, R.B. Nadelman.

Critical revision of the article for important intellectual content: G.P. Wormser, R. Ramanathan, J. Nowakowski, P. Visintainer, R.B. Nadelman.

Final approval of the article: G.P. Wormser, R. Ramanathan, J. Nowakowski, D. McKenna, D. Holmgren, P. Visintainer, R. Dornbush, B. Singh, R.B. Nadelman.

Provision of study materials or patients: G.P. Wormser, J. Nowakowski, R.B. Nadelman.

Statistical expertise: G.P. Wormser, R. Ramanathan, P. Visintainer, R. Dornbush.

Obtaining of funding: R.B. Nadelman.

Administrative, technical, or logistic support: G.P. Wormser, R. Ramanathan, D. McKenna, D. Holmgren, P. Visintainer, R. Dornbush, B. Singh, R.B. Nadelman.

Collection and assembly of data: G.P. Wormser, R. Ramanathan, J. Nowakowski, D. McKenna, D. Holmgren, P. Visintainer, B. Singh, R.B. Nadelman.

Ann Intern Med. 2003;138(9):697-704. doi:10.7326/0003-4819-138-9-200305060-00005
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Patients at least 16 years of age who had erythema migrans and satisfied the U.S. Centers for Disease Control and Prevention's surveillance definition of Lyme disease (an annular erythematous skin lesion ≥ 5 cm in diameter) (8) entered the study between 1992 and 1994. Volunteers were recruited primarily through the walk-in Lyme Disease Diagnostic Center at the Westchester Medical Center, Valhalla, New York. Exclusion criteria included pregnancy or lactation, allergy to a tetracycline or a β-lactam antibiotic, receipt of antibiotic treatment for Lyme disease for more than 48 hours before enrollment, meningitis or advanced heart block, or any underlying conditions that might interfere with evaluability or follow-up. All patients gave written informed consent, and the institutional review board at New York Medical College approved the study protocol.

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Summary for Patients

Duration of Antibiotic Treatment for Early Lyme Disease

The study is titled “Duration of Antibiotic Therapy for Early Lyme Disease. A Randomized, Double-Blind, Placebo- Controlled Trial.” It is in the 6 May 2003 issue of Annals of Internal Medicine (volume 138, pages 697-704). The authors are G.P. Wormser, R. Ramanathan, J. Nowakowski, D. McKenna, D. Holmgren, P. Visintainer, R. Dornbush, B. Singh, and R.B. Nadelman.


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