RESUMEN
BACKGROUND: The treatment of multidrug-resistant tuberculosis (MDR-TB) is currently based upon expert opinion and findings from case series, rather than upon randomised clinical trials (RCTs). OBJECTIVE: To describe the challenges encountered during an RCT for the treatment of MDR-TB. METHODS: Tuberculosis Trials Consortium Study 30 was a pilot, Phase I/II, double-blind, placebo-controlled, RCT of the safety and tolerability of 16 weeks of daily, low-dose linezolid treatment for MDR-TB. RESULTS: A total of 36 patients, 56% of the target of 64 patients, consented to participate, for an average of 0.69 enrolments per week. Of the 36 patients enrolled, only 25 (69%) completed at least 90 doses of study treatment. Among the 12 (33%) patients who did not complete all 112 doses of the study treatment, the median time to study withdrawal was 15 days (range 0-92). After the study, we discovered discordance between treatment assignment and study drug for at least 9 (25%) of the 36 patients. CONCLUSIONS: Recruitment and retention in this MDR-TB clinical trial posed substantial challenges, suggesting the need for a large, multidisciplinary group of study staff to support the participants. Withdrawal tended to occur early in study treatment. The discrepancy in assigned study medication reflects the need for stronger administrative controls for study drugs.
Asunto(s)
Acetamidas/administración & dosificación , Antituberculosos/administración & dosificación , Oxazolidinonas/administración & dosificación , Tuberculosis Resistente a Múltiples Medicamentos/tratamiento farmacológico , Tuberculosis Pulmonar/tratamiento farmacológico , Acetamidas/efectos adversos , Acetamidas/sangre , Acetamidas/farmacocinética , Antituberculosos/efectos adversos , Antituberculosos/sangre , Antituberculosos/farmacocinética , Terapia por Observación Directa , Método Doble Ciego , Monitoreo de Drogas , Femenino , Humanos , Linezolid , Masculino , Mycobacterium tuberculosis/aislamiento & purificación , Oxazolidinonas/efectos adversos , Oxazolidinonas/sangre , Oxazolidinonas/farmacocinética , Pacientes Desistentes del Tratamiento , Proyectos Piloto , Proyectos de Investigación , Sudáfrica , Esputo/microbiología , Resultado del Tratamiento , Tuberculosis Resistente a Múltiples Medicamentos/diagnóstico , Tuberculosis Resistente a Múltiples Medicamentos/microbiología , Tuberculosis Pulmonar/diagnóstico , Tuberculosis Pulmonar/microbiologíaRESUMEN
La ruptura "espontánea" de la arteria epigástrica constituye una afección vascular de baja incidencia con un diagnóstico que plantea dificultades en la mayoría de los casos. Los signos y síntomas son muy variados confundiéndose generalmente con procesos intraabdominales. Presentamos un caso cuyo hematoma originó una trombosis venosa profunda íleo femoral como forma de presentación. La misma no fue hallada en la bibliografía revisada y generó al inicio una incorrecta conducta terapéutica
Asunto(s)
Humanos , Femenino , Anciano , Arterias Epigástricas/patología , Hematoma , Trombosis de la Vena , Dolor Abdominal , Vena Femoral , Hematoma , Músculos Abdominales/patología , Rotura Espontánea/complicaciones , Rotura Espontánea/diagnóstico , Vena Safena , Vena Ilíaca/patología , Vena Poplítea/patología , Trombosis de la VenaRESUMEN
La ruptura "espontánea" de la arteria epigástrica constituye una afección vascular de baja incidencia con un diagnóstico que plantea dificultades en la mayoría de los casos. Los signos y síntomas son muy variados confundiéndose generalmente con procesos intraabdominales. Presentamos un caso cuyo hematoma originó una trombosis venosa profunda íleo femoral como forma de presentación. La misma no fue hallada en la bibliografía revisada y generó al inicio una incorrecta conducta terapéutica (AU)
Asunto(s)
Humanos , Femenino , Anciano , Arterias Epigástricas/patología , Trombosis de la Vena/etiología , Hematoma/etiología , Rotura Espontánea/diagnóstico , Rotura Espontánea/complicaciones , Vena Poplítea/patología , Vena Safena/patología , Vena Ilíaca/patología , Vena Femoral/patología , Trombosis de la Vena/complicaciones , Dolor Abdominal/etiología , Músculos Abdominales/patología , Hematoma/complicacionesRESUMEN
An increasing proportion of the U.S. population resides in nursing homes (NHs). No surveillance system exists for infections in these facilities. To determine the incidence and types of infections in NH residents, and to identify predictors of death among residents with infections, we initiated a surveillance system at 13 NHs in California during a 6-month period from October 1989 through March 1990. The study included 1754 residents, among whom 835 infections were identified during the study period. The most common infections were urinary tract infections (UTIs; 286, 34.2%), respiratory tract infections (RTIs; 259, 31%), and skin infections (150, 17.9%). Of the 259 residents with respiratory tract infections, 69 (27%) had pneumonia. Antimicrobials were prescribed for 646 (77%) of the infectious episodes. Residents with pneumonia were more likely to die than residents with other infections (4 of 69 versus 12 of 766; P = 0.04). Symptoms of altered body temperature (fever, hypothermia, chills) and change in mental status also were associated with an increased risk of a fatal outcome (10 of 260 versus 6 of 575; P = 0.01) and (7 of 127 versus 9 of 708; P = 0.004). This study suggests that the most common infections among NH residents are UTIs, RTIs, and skin infections. Pneumonia, symptoms of fever, and mental status changes all were associated with increased mortality. The frequency of infections among NH residents and their impact on resident outcome highlights the need for infectious disease surveillance in this population.
