A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seronegative Chronic Lyme Disease
Colección de datos
Infecciones por Borrelia+4
+ Enfermedades transmitidas por vectores
+ Infecciones Bacterianas y Micosis
Estudio de Tratamiento
Resumen
Sixty-six 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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 66 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: You may be eligible for this study if you: * Are at least 18 years of age. * Are seronegative 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, beginning 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 or 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. * Have tested seropositive by Western Blot (these patients may be offered enrollment in seropositive study).
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación