ABSTRACT
OBJECTIVE: To prove that 7-day courses of antibiotics for bloodstream infections caused by members of the Enterobacterales (eBSIs) allow a reduction in patients' exposure to antibiotics while achieving clinical outcomes similar to those of 14-day schemes. METHODS: A randomized trial was performed. Adult patients developing eBSI with appropriate source control were assigned to 7 or 14 days of treatment, and followed 28 days after treatment cessation; treatments could be resumed whenever necessary. The primary endpoint was days of treatment at the end of follow-up. Clinical outcomes included clinical cure, relapse of eBSI and relapse of fever. A superiority margin of 3 days was set for the primary endpoint, and a non-inferiority margin of 10% was set for clinical outcomes. Efficacy and safety were assessed together with a DOOR/RADAR (desirability of outcome ranking and response adjusted for duration of antibiotic risk) analysis. RESULTS: 248 patients were assigned to 7 (n = 119) or 14 (n = 129) days of treatment. In the intention-to-treat analysis, median days of treatment at the end of follow-up were 7 and 14 days (difference 7, 95%CI 7-7). The non-inferiority margin was also met for clinical outcomes, except for relapse of fever (-0.2%, 95%CI -10.4 to 10.1). The DOOR/RADAR showed that 7-day schemes had a 77.7% probability of achieving better results than 14-day treatments. CONCLUSIONS: 7-day schemes allowed a reduction in antibiotic exposure of patients with eBSI while achieving outcomes similar to those of 14-day schemes. The possibility of relapsing fever in a limited number of patients, without relevance to final outcomes, may not be excluded, but was overcome by the benefits of shortening treatments.
Subject(s)
Anti-Bacterial Agents , Sepsis , Adult , Anti-Bacterial Agents/therapeutic use , Fever/drug therapy , Humans , Sepsis/drug therapyABSTRACT
Fundamento y objetivo: Aunque se conoce la relación entre la bacteriemia por Streptococcus bovis (S. bovis) y el cáncer de colon, cirrosis hepática u otras neoplasias, no se ha establecido un protocolo de estudio para descartar estas enfermedades subyacentes a la bacteriemia. Nuestro objetivo fue describir la bacteriemia por S. bovis y las enfermedades asociadas.Pacientes y método: Estudio multicéntrico, retrospectivo de cohortes. Se incluyeron las bacteriemias por S. bovis entre 2001 y 2009. Las variables principales fueron: neoplasia colónica, neoplasias en otras localizaciones o cirrosis hepática. Se recogieron variables epidemiológicas, relacionadas con la bacteriemia, antecedentes personales, familiares, datos clínicos y analíticos. Resultados: Se incluyeron 93 pacientes. Un 25% de los individuos tuvo neoplasia de colon. Un 57% de ellos fueron casos concomitantes con la bacteriemia y 6 fueron diagnósticos posteriores a ella (mediana [Q1-Q3] de tiempo bacteriemia-diagnóstico neoplasia de 2,6 meses [1-11]), con un máximo de 15,4 meses. Catorce (15%) pacientes padecían alguna neoplasia no colónica (mayoritariamente biliopancreática [6 casos] y esofagogástrica [3 casos]). Hubo 3 (21%) casos concomitantes con la bacteriemia y 2 posteriores a ella (a 1,2 y 10,4 meses). Veintiún (23%) enfermos tenían cirrosis hepática.Conclusiones: A los pacientes con bacteriemia por S. bovis es necesario realizarles un estudio encaminado a descartar enfermedades subyacentes. Sugerimos que se incluyan, al menos: una prueba de imagen colónica, preferentemente colonoscopia; un estudio hepático mediante analítica, ecografía abdominal o un método de medición de fibrosis hepática; una endoscopia digestiva alta; y una prueba de imagen del área biliopancreática como la colangiorresonancia magnética
Background and objective: It is well-known the relationship between Streptococcus bovis (S. bovis) bacteremia and colon cancer, liver cirrhosis and others neoplasms. However, a study protocol to rule out these underlying diseases has not been carried out yet. Our objective was to describe S. bovis bacteremia and associated diseases. Patients and method: Multicenter, retrospective cohort study. S. bovis bacteremias episodes between 2001 and 2009 were included. Mean variables: colon neoplasm, non-colonic neoplasm or liver cirrhosis. Epidemiologist aspects, bacteremia related variables, personal and familiar history and clinical and analytical data were collected.Results: Ninety three patients were included. One out of four individuals had a colon neoplasm. Fifty seven per cent were concomitant cases with bacteremia and six cases were diagnosed after bacteremia (time bacteremia-diagnosis of neoplasm [months], median [Q1-Q3], 2.6 [1-11]). Fourteen (15%) patients were diagnosed with any non-colonic neoplasm (mainly biliary and pancreatic [6 cases] or esophagus-gastric [3 cases]). There were three patients (21%) with concomitant bacteremia non-colonic neoplasm and two after it (1.2 and 10.4 months). Twenty-one (23%) patients suffered from liver cirrhosis. Conclusions: Patients with S. bovis bacteremia must undergo a study designed to rule out underlying diseases. We suggest that this study should include: a colonic evaluation, ideally by colonoscopy, a liver evaluation by serum chemistry, an abdominal ultrasound scan or a method of liver fibrosis assessment, a gastroscopy and an evaluation of biliary and pancreatic areas by magnetic resonance imaging
Subject(s)
Humans , Bacteremia/complications , Streptococcus bovis/pathogenicity , Streptococcal Infections/complications , Retrospective Studies , Colonic Neoplasms/complications , Liver Cirrhosis/complications , Cholangiopancreatography, Magnetic ResonanceABSTRACT
BACKGROUND AND OBJECTIVE: It is well-known the relationship between Streptococcus bovis (S. bovis) bacteremia and colon cancer, liver cirrhosis and others neoplasms. However, a study protocol to rule out these underlying diseases has not been carried out yet. Our objective was to describe S. bovis bacteremia and associated diseases. PATIENTS AND METHOD: Multicenter, retrospective cohort study. S. bovis bacteremias episodes between 2001 and 2009 were included. Mean variables: colon neoplasm, non-colonic neoplasm or liver cirrhosis. Epidemiologist aspects, bacteremia related variables, personal and familiar history and clinical and analytical data were collected. RESULTS: Ninety three patients were included. One out of four individuals had a colon neoplasm. Fifty seven per cent were concomitant cases with bacteremia and six cases were diagnosed after bacteremia (time bacteremia-diagnosis of neoplasm [months], median [Q1-Q3], 2.6 [1-11]). Fourteen (15%) patients were diagnosed with any non-colonic neoplasm (mainly biliary and pancreatic [6 cases] or esophagus-gastric [3 cases]). There were three patients (21%) with concomitant bacteremia non-colonic neoplasm and two after it (1.2 and 10.4 months). Twenty-one (23%) patients suffered from liver cirrhosis. CONCLUSIONS: Patients with S. bovis bacteremia must undergo a study designed to rule out underlying diseases. We suggest that this study should include: a colonic evaluation, ideally by colonoscopy, a liver evaluation by serum chemistry, an abdominal ultrasound scan or a method of liver fibrosis assessment, a gastroscopy and an evaluation of biliary and pancreatic areas by magnetic resonance imaging.
