Dexamethasone in Cryptococcal Meningitis
Flucytosine
+ Fluconazole
+ Amphotericin B
Infecciones Transmitidas por la Sangre+22
+ Enfermedades Neuroinflamatorias
+ Enfermedades Urogenitales
Estudio de Tratamiento
Resumen
In AIDS patients with cryptococcal meningitis, a correlation has been found between early death and elevated intracranial pressure. Since dexamethasone has been found to reduce intracranial pressure resulting from other forms of meningitis, it may be of benefit in AIDS patients with cryptococcal meningitis. Patients are randomized to receive dexamethasone or placebo every 6 hours for 72 hours (days 1 through 3). Additionally, standard antifungal therapy with amphotericin B and flucytosine is given for 2 weeks, followed by fluconazole for 8 weeks. Lumbar punctures will be performed daily on days 1 through 3, on days 7 and 14, and at week 10.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 36 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 13 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 Concurrent Medication: Allowed: Aerosolized pentamidine or systemic chemoprophylaxis for PCP. Preventive therapy for steroid-associated ulcers and any other therapies required to manage steroid toxicity (e.g., insulin). Patients must have: Documented initial episode or relapse of acute cryptococcal meningitis. (NOTE: Patients must be untreated for this episode except for administration of a test dose of 1 g or less amphotericin B.) Acute cryptococcal meningitis with cerebrospinal fluid opening pressure >= 250 mm H2O prior to receipt of antifungal therapy for this episode. Documented HIV infection OR a diagnosis of AIDS based on a documented AIDS-defining opportunistic infection. Ability to begin therapy within 8 hours after the pre-entry lumbar puncture. Consent of parent or guardian if less than 18 years of age. NOTE: Comatose patients eligible provided informed consent can be provided by guardian or next of kin. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Concurrent CNS disease such as another infection or neoplasm that would interfere with assessment of response. Prison incarceration. Concurrent Medication: Excluded: Acetazolamide, mannitol, urea preparations, and other corticosteroids during the first 72 hours of the study. Treatment or prophylaxis with other systemic antifungal agents at any time. Antiretroviral therapy during the first 72 hours of the study. Prior Medication: Excluded within 7 days prior to study entry: Corticosteroids, mannitol, urea preparations, acetazolamide, or more than 24 hours of phenytoin.
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 14 ubicaciones
Univ of Alabama at Birmingham
Birmingham, United StatesAbrir Univ of Alabama at Birmingham en Google MapsGeorgetown Univ Med Ctr
Washington D.C., United StatesUniv of Miami School of Medicine
Miami, United StatesNorthwestern Univ Med School
Chicago, United States