Results of a multicenter, controlled, randomized clinical trial evaluating the combination of piperacillin/tazobactam and tigecycline in high-risk hematologic patients with cancer with febrile neutropenia
| Autor: | Monica Bocchia, Laura Cudillo, Anna Chierichini, Massimo Offidani, Rosa Fanci, Francesco Fabbiano, Nicola Cascavilla, Bruno Martino, Giovanni Martinelli, Giuseppe Gentile, Robin Foà, Annunziata Manna, Antonella Ferrari, Mario Luppi, Giorgina Specchia, Giovanni Quarta, Valeria Primon, Giuseppe Milone, Giampaolo Bucaneve, Marco Picardi, Albano Del Favero, Stelvio Ballanti, Eliana Zuffa, Prassede Salutari, Renato Cantaffa, Alessandra Micozzi |
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| Přispěvatelé: | Bucaneve, G, Micozzi, A, Picardi, Marco, Ballanti, S, Cascavilla, N, Salutari, P, Specchia, G, Fanci, R, Luppi, M, Cudillo, L, Cantaffa, R, Milone, G, Bocchia, M, Martinelli, G, Offidani, M, Chierichini, A, Fabbiano, F, Quarta, G, Primon, V, Martino, B, Manna, A, Zuffa, E, Ferrari, A, Gentile, G, Fo?, R, Del Favero, A. |
| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Adolescent Combination therapy Penicillanic Acid Aged Anti-Bacterial Agents Antineoplastic Agents Bacteremia Chemotherapy-Induced Febrile Neutropenia Drug Combinations Female Hematologic Neoplasms Humans Middle Aged Minocycline Piperacillin Risk Factors Young Adult Tigecycline Tazobactam Loading dose law.invention Randomized controlled trial law piperacillin/tazobactam and tigecycline Internal medicine medicine high-risk hematologic patient business.industry medicine.disease Surgery febrile neutropenia Oncology Piperacillin/tazobactam business Settore MED/15 - Malattie del Sangue Febrile neutropenia medicine.drug |
| Popis: | Purpose Empiric antibiotic monotherapy is considered the standard of treatment for febrile neutropenic patients with cancer, but this approach may be inadequate because of the increasing prevalence of infections caused by multidrug resistant (MDR) bacteria. Patients and Methods In this multicenter, open-label, randomized, superiority trial, adult, febrile, high-risk neutropenic patients (FhrNPs) with hematologic malignancies were randomly assigned to receive piperacillin/tazobactam (4.5 g intravenously every 8 hours) with or without tigecycline (50 mg intravenously every 12 hours; loading dose 100 mg). The primary end point was resolution of febrile episode without modifications of the initial allocated treatment. Results Three hundred ninety FhrNPs were enrolled (combination/monotherapy, 187/203) and were included in the intention-to-treat analysis (ITTA). The ITTA revealed a successful outcome in 67.9% v 44.3% of patients who had received combination therapy and monotherapy, respectively (127/187 v 90/203; absolute difference in risk (adr), 23.6%; 95% CI, 14% to 33%; P < .001). The combination regimen proved better than monotherapy in bacteremias (adr, 32.8%; 95% CI, 19% to 46%; P < .001) and in clinically documented infections (adr, 36%; 95% CI, 9% to 64%; P < .01). Mortality and number of adverse effects were limited and similar in the two groups. Conclusion The combination of piperacillin/tazobactam and tigecycline is safe, well tolerated, and more effective than piperacillin/tazobactam alone in febrile, high-risk, neutropenic hematologic patients with cancer. In epidemiologic settings characterized by a high prevalence of infections because of MDR microorganisms, this combination could be considered as one of the first-line empiric antibiotic therapies. |
| Databáze: | OpenAIRE |
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