Metronidazol en la prevención de diarrea asociada a antibióticos e infección por Clostridium difficile en pacientes hospitalizados de alto riesgo / Metronidazole in the prevention of antibiotic-associated diarrhoea and Clostridium difficile infection in high-risk hospitalised patients

ANTECEDENTES: La aparición de diarrea intrahospitalaria supone un evento de alto impacto en la morbimortalidad de pacientes hospitalizados, la quimioprofilaxis con antibióticos en pacientes seleccionados podría resultar en una herramienta costo-efectiva para su prevención. MÉTODO: Se realizó un estudio prospectivo, randomizado, abierto, en un hospital de tercer nivel de la ciudad de México, seleccionando pacientes con alto riesgo de adquirir diarrea intrahospitalaria, se asignó pacientes a un grupo de metronidazol 500mg vía oral cada 8 h durante 7 días y un grupo de observación. El resultado primario fue determinar la presencia de diarrea asociada a antibióticos e infección por Clostridium difficile (C. difficile) durante los 7 días de evaluación. Aprobado por el comité de ética institucional. Número de registro (11.2017) del 14 de marzo de 2017. RESULTADOS: De 116 pacientes que cumplieron criterios de inclusión, 96 fueron analizados, 41 en el grupo de intervención y 55 en el grupo de observación, la diarrea asociada a antibióticos se presentó en un 4,9% de pacientes en el grupo de intervención y en un 16,4% en el grupo de observación (odds ratio [OR] 0,26 (0,05-1,29) p = 0,109). La infección por C. difficile se presentó en el 0% de los pacientes en el primer grupo y en el 9,1% en el segundo grupo (odds ratio [OR] 0,91 (0,84-0,99) p = 0,069). CONCLUSIONES: El uso de metronidazol para prevención de diarrea asociada a antibióticos no se relacionó con disminución en su aparición, mientras que para infección por C. difficile podría resultar en una alternativa efectiva en seleccionados pacientes de alto riesgo. Éste es el primer estudio prospectivo diseñado para este fin. Se requieren a futuro nuevos estudios que involucren mayor número de pacientes

BACKGROUND: In-hospital diarrhoea has a high impact on morbidity and mortality rates among hospitalised patients. Chemoprophylaxis with antibiotics in selected patients could be a cost-effective tool for prevention. METHODS: A prospective randomised, open-label study was conducted in a tertiary hospital in Mexico City, selecting patients at high risk of acquiring in-hospital diarrhoea and assigning them to a group taking metronidazole 500mg orally every eight hours for seven days or an observation group. The primary endpoint was the presence of antibiotic-associated diarrhoea and Clostridium difficile (C. difficile) infection during the seven days of evaluation. The study was approved by the institutional ethics committee. Registration number (11.2017) of 14 March 2017. RESULTS: Of the 116 patients who met the inclusion criteria, 96 were analysed, 41 in the intervention group and 55 in the observation group: 4.9% of patients in the intervention group and 16.4% in the observation group developed antibiotic-associated diarrhoea (odds ratio [OR] 0.26 (0.05-1.29); p =.109). 0% of patients in the intervention group and 9.1% in the observation group developed C. difficile infection (odds ratio [OR] 0.91 (0.84-0.99); p =.069). CONCLUSIONS: Metronidazole prophylaxis did not result in a reduction in antibiotic-associated diarrhoea. It could, however, be an effective measure for preventing C. difficile infection in selected high-risk patients. This was the first prospective study designed for this purpose. New studies that involve a larger number of patients are required in the future

Metronidazole in the prevention of antibiotic-associated diarrhoea and Clostridium difficile infection in high-risk hospitalised patients. / Metronidazol en la prevención de diarrea asociada a antibióticos e infección por Clostridium difficile en pacientes hospitalizados de alto riesgo.

BACKGROUND: In-hospital diarrhoea has a high impact on morbidity and mortality rates among hospitalised patients. Chemoprophylaxis with antibiotics in selected patients could be a cost-effective tool for prevention. METHODS: A prospective randomised, open-label study was conducted in a tertiary hospital in Mexico City, selecting patients at high risk of acquiring in-hospital diarrhoea and assigning them to a group taking metronidazole 500mg orally every eight hours for seven days or an observation group. The primary endpoint was the presence of antibiotic-associated diarrhoea and Clostridium difficile (C. difficile) infection during the seven days of evaluation. The study was approved by the institutional ethics committee. Registration number (11.2017) of 14 March 2017. RESULTS: Of the 116 patients who met the inclusion criteria, 96 were analysed, 41 in the intervention group and 55 in the observation group: 4.9% of patients in the intervention group and 16.4% in the observation group developed antibiotic-associated diarrhoea (odds ratio [OR] 0.26 (0.05-1.29); p =.109). 0% of patients in the intervention group and 9.1% in the observation group developed C. difficile infection (odds ratio [OR] 0.91 (0.84-0.99); p =.069). CONCLUSIONS: Metronidazole prophylaxis did not result in a reduction in antibiotic-associated diarrhoea. It could, however, be an effective measure for preventing C. difficile infection in selected high-risk patients. This was the first prospective study designed for this purpose. New studies that involve a larger number of patients are required in the future.