A Controlled Trial of Antimicrobial Prophylaxis for Lyme Disease after Deer-Tick Bites

Borrelia burgdorferi, which causes Lyme disease, is transmitted by deer ticks (Ixodes dammini) in the northeastern and midwestern United States. Although deer-tick bites are common in areas in which the disease is endemic, there is uncertainty about how to manage the care of persons who are bitten. To assess the risk of infection with B. burgdorferi and the efficacy of prophylactic antimicrobial treatment after a deer-tick bite, we conducted a double-blind, placebo-controlled trial in an area of southeastern Connecticut in which Lyme disease is endemic. Children and adults who had been bitten by deer ticks were randomly assigned to receive either amoxicillin or placebo for 10 days. Subjects were followed for one year for clinical manifestations of Lyme disease. Serum samples obtained at enrollment and six weeks and three months later were tested for antibodies against B. burgdorferi. Of the 387 subjects, 205 (53 percent) were assigned to receive amoxicillin and 182 (47 percent) to receive placebo. Of 344 deer ticks submitted and analyzed by the polymerase chain reaction, 15 percent were infected with B. burgdorferi. Erythema migrans developed in two subjects, both of whom had received placebo. There were no asymptomatic seroconversions and no late manifestations of Lyme disease. The risk of infection with B. burgdorferi in the placebo-treated subjects was 1.2 percent (95 percent confidence interval, 0.1 to 4.1 percent), which was not significantly different (P = 0.22) from the risk in the amoxicillin-treated subjects (0 percent; 95 percent confidence interval, 0 to 1.5 percent). Even in an area in which Lyme disease is endemic, the risk of infection with B. burgdorferi after a recognized deer-tick bite is so low that prophylactic antimicrobial treatment is not routinely indicated. (N Engl J Med 1992;327:1769–73.), LYME disease, caused by Borrelia burgdorferi, is transmitted by the deer tick, Ixodes dammini, in the northeastern United States.¹ In areas in which the disease is endemic, deer-tick bites are common and can cause tremendous anxiety, but there is uncertainty about how the care of persons who are bitten should be managed. We conducted a double-blind, placebo-controlled, randomized clinical trial to assess the risk of infection with B. burgdorferi after a deer-tick bite and to determine whether antimicrobial prophylaxis is effective in reducing this risk. Methods Enrollment and Randomization of the Subjects From May 1989 through November 1991,…