Objectives: Data about the efficacy of ertapenem for the treatment of bloodstream infections (BSI) due to ESBL-producing Enterobacteriaceae (ESBL-E) are limited. We compared the clinical efficacy of ertapenem and other carbapenems in monomicrobial BSI due to ESBL-E. Methods: A multinational retrospective cohort study (INCREMENT project) was performed (ClinicalTrials.gov identifier: NCT01764490). Patients given monotherapy with ertapenem or other carbapenems were compared. Empirical and targeted therapies were analysed. Propensity scores were used to control for confounding; sensitivity analyses were performed in subgroups. The outcome variables were cure/improvement rate at day 14 and all-cause 30 day mortality. Results: The empirical therapy cohort (ETC) and the targeted therapy cohort (TTC) included 195 and 509 patients, respectively. Cure/improvement rateswere 90.6% with ertapenem and 75.5% with other carbapenems (P=0.06) in the ETC and 89.8% and 82.6% (P=0.02) in the TTC, respectively; 30 day mortality rates were 3.1% and 23.3% (P=0.01) in the ETC and 9.3% and 17.1% (P=0.01) in the TTC, respectively. Adjusted ORs (95% CI) for cure/improvement with empirical and targeted ertapenem were 1.87 (0.24-20.08; P=0.58) and 1.04 (0.44- 2.50; P=0.92), respectively. For the propensity-matched cohorts it was 1.18 (0.43-3.29; P=0.74). Regarding 30 day mortality, the adjusted HR (95% CI) for targeted ertapenem was 0.93 (0.43-2.03; P=0.86) and for the propensity-matched cohorts it was 1.05 (0.46-2.44; P=0.90). Sensitivity analyses were consistent except for patients with severe sepsis/septic shock, which showed a non-significant trend favouring other carbapenems. Conclusions: Ertapenem appears as effective as other carbapenems for empirical and targeted therapy of BSI due to ESBL-E, but further studies are needed for patients with severe sepsis/septic shock.

Gutiérrez Gutiérrez, B., Bonomo, R. A., Carmeli, Y., Paterson, D. L., Almirante, B., Martínez Martínez, L., Oliver, A., Calbo, E., Peña, C., Akova, M., Pitout, J., Origüen, J., Pintado, V., García Vázquez, E., Gasch, O., Hamprecht, A., Prim, N., Tumbarello, M., Bou, G., Viale, P., Tacconelli, E., Almela, M., Pérez, F., Giamarellou, H., Cisneros, J. M., Schwaber, M. J., Venditti, M., Lowman, W., Bermejo, J., Hsueh, P. R., Mora Rillo, M., Gracia Ahulfinger, I., Pascual, A., Rodríguez Baño, J., Karaiskos, I., Trecarichi, E. M., Losito, A. R., Hernández, A., Gómez, J., Navarro, F., Mirelis, B., Larrosa, N., Puig, M., Rucci, V., Bartoletti, M., Giannella, M., Riemenschneider, F., Badia, C., Xercavins, M., Gálvez, J., De Cueto, M., Salamanca, E., Falcone, M., Russo, A., Daikos, G., Paterson, D. L., Roilides, E., Iosifidis, E., Doi, Y., Tuon, F. F., San Juan, R., Fernández Ruiz, M., Molina, J., González, V., Ruiz De Gopegui, E., Marinescu, C. I., Fariñas, M. C., Cano, M. E., Gozalo, M., Paño Pardo, J. R., Navarro San Francisco, C., Gómez Zorrilla, S., Tubau, F., Pournaras, S., Tsakris, A., Zarkotou, O., Azap, Ö. K., Souli, M., Antoniadou, A., Poulakou, G., Virmani, D., Machuca, I., Pérez Nadales, E., Torre Cisneros, J., Helvaci, Ö., Sahin, A. O., Cantón, R., Ruiz, P., Fontanals, D., Jové, E., Ertapenem for the treatment of bloodstream infections due to ESBL-producing Enterobacteriaceae: A multinational pre-registered cohort study, <<JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY>>, 2016; 71 (6): 1672-1680. [doi:10.1093/jac/dkv502] [http://hdl.handle.net/10807/92383]

Ertapenem for the treatment of bloodstream infections due to ESBL-producing Enterobacteriaceae: A multinational pre-registered cohort study

Tumbarello, Mario;Tacconelli, Evelina;Trecarichi, Enrico Maria;Losito, Angela Raffaella;
2016

Abstract

Objectives: Data about the efficacy of ertapenem for the treatment of bloodstream infections (BSI) due to ESBL-producing Enterobacteriaceae (ESBL-E) are limited. We compared the clinical efficacy of ertapenem and other carbapenems in monomicrobial BSI due to ESBL-E. Methods: A multinational retrospective cohort study (INCREMENT project) was performed (ClinicalTrials.gov identifier: NCT01764490). Patients given monotherapy with ertapenem or other carbapenems were compared. Empirical and targeted therapies were analysed. Propensity scores were used to control for confounding; sensitivity analyses were performed in subgroups. The outcome variables were cure/improvement rate at day 14 and all-cause 30 day mortality. Results: The empirical therapy cohort (ETC) and the targeted therapy cohort (TTC) included 195 and 509 patients, respectively. Cure/improvement rateswere 90.6% with ertapenem and 75.5% with other carbapenems (P=0.06) in the ETC and 89.8% and 82.6% (P=0.02) in the TTC, respectively; 30 day mortality rates were 3.1% and 23.3% (P=0.01) in the ETC and 9.3% and 17.1% (P=0.01) in the TTC, respectively. Adjusted ORs (95% CI) for cure/improvement with empirical and targeted ertapenem were 1.87 (0.24-20.08; P=0.58) and 1.04 (0.44- 2.50; P=0.92), respectively. For the propensity-matched cohorts it was 1.18 (0.43-3.29; P=0.74). Regarding 30 day mortality, the adjusted HR (95% CI) for targeted ertapenem was 0.93 (0.43-2.03; P=0.86) and for the propensity-matched cohorts it was 1.05 (0.46-2.44; P=0.90). Sensitivity analyses were consistent except for patients with severe sepsis/septic shock, which showed a non-significant trend favouring other carbapenems. Conclusions: Ertapenem appears as effective as other carbapenems for empirical and targeted therapy of BSI due to ESBL-E, but further studies are needed for patients with severe sepsis/septic shock.
Inglese
http://jac.oxfordjournals.org/
Gutiérrez Gutiérrez, B., Bonomo, R. A., Carmeli, Y., Paterson, D. L., Almirante, B., Martínez Martínez, L., Oliver, A., Calbo, E., Peña, C., Akova, M., Pitout, J., Origüen, J., Pintado, V., García Vázquez, E., Gasch, O., Hamprecht, A., Prim, N., Tumbarello, M., Bou, G., Viale, P., Tacconelli, E., Almela, M., Pérez, F., Giamarellou, H., Cisneros, J. M., Schwaber, M. J., Venditti, M., Lowman, W., Bermejo, J., Hsueh, P. R., Mora Rillo, M., Gracia Ahulfinger, I., Pascual, A., Rodríguez Baño, J., Karaiskos, I., Trecarichi, E. M., Losito, A. R., Hernández, A., Gómez, J., Navarro, F., Mirelis, B., Larrosa, N., Puig, M., Rucci, V., Bartoletti, M., Giannella, M., Riemenschneider, F., Badia, C., Xercavins, M., Gálvez, J., De Cueto, M., Salamanca, E., Falcone, M., Russo, A., Daikos, G., Paterson, D. L., Roilides, E., Iosifidis, E., Doi, Y., Tuon, F. F., San Juan, R., Fernández Ruiz, M., Molina, J., González, V., Ruiz De Gopegui, E., Marinescu, C. I., Fariñas, M. C., Cano, M. E., Gozalo, M., Paño Pardo, J. R., Navarro San Francisco, C., Gómez Zorrilla, S., Tubau, F., Pournaras, S., Tsakris, A., Zarkotou, O., Azap, Ö. K., Souli, M., Antoniadou, A., Poulakou, G., Virmani, D., Machuca, I., Pérez Nadales, E., Torre Cisneros, J., Helvaci, Ö., Sahin, A. O., Cantón, R., Ruiz, P., Fontanals, D., Jové, E., Ertapenem for the treatment of bloodstream infections due to ESBL-producing Enterobacteriaceae: A multinational pre-registered cohort study, <>, 2016; 71 (6): 1672-1680. [doi:10.1093/jac/dkv502] [http://hdl.handle.net/10807/92383]
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