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US Food and Drug Administration (FDA): Benefit-Risk Considerations for Cefiderocol (Fetroja®).
Naseer, Shabnam; Weinstein, Edward A; Rubin, Daniel B; Suvarna, Kalavati; Wei, Xiaohui; Higgins, Karen; Goodwin, Avery; Jang, Seong H; Iarikov, Dmitri; Farley, John; Nambiar, Sumathi.
Afiliación
  • Naseer S; Division of Anti-Infectives, Office of Infectious Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Weinstein EA; Division of Anti-Infectives, Office of Infectious Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Rubin DB; Division of Biometrics IV, Office of Biostatistics, Center for Drug Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
  • Suvarna K; Division of Anti-Infectives, Office of Infectious Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Wei X; Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
  • Higgins K; Division of Biometrics IV, Office of Biostatistics, Center for Drug Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
  • Goodwin A; Division of Anti-Infectives, Office of Infectious Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Jang SH; Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
  • Iarikov D; Division of Anti-Infectives, Office of Infectious Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Farley J; Division of Anti-Infectives, Office of Infectious Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Nambiar S; Division of Anti-Infectives, Office of Infectious Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
Clin Infect Dis ; 72(12): e1103-e1111, 2021 06 15.
Article en En | MEDLINE | ID: mdl-33393598
In November 2019, the Food and Drug Administration (FDA) approved cefiderocol for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis caused by susceptible gram-negative bacteria in adults with limited to no alternative treatment options based on a randomized, double-blind, noninferiority cUTI trial (APEKS-cUTI). In a randomized, open-label trial (CREDIBLE-CR) in patients with cUTI, nosocomial pneumonia, bloodstream infections, or sepsis due to carbapenem-resistant gram-negative bacteria, an increase in all-cause mortality was observed in patients treated with cefiderocol as compared to best available therapy. The cause of the increased mortality was not established, but some deaths were attributed to treatment failure. Preliminary data from a randomized, double-blind trial (APEKS-NP) in patients with nosocomial pneumonia due to carbapenem-susceptible gram-negative bacteria showed a similar rate of mortality as compared to meropenem. We describe the uncertainties and challenges in the interpretation of the CREDIBLE-CR trial and some benefit-risk considerations for the use of cefiderocol in clinical practice. Clinical Trials Registration: NCT02321800.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Cefalosporinas / Antibacterianos Tipo de estudio: Clinical_trials / Etiology_studies / Risk_factors_studies Límite: Adult / Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Infect Dis Asunto de la revista: DOENCAS TRANSMISSIVEIS Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Cefalosporinas / Antibacterianos Tipo de estudio: Clinical_trials / Etiology_studies / Risk_factors_studies Límite: Adult / Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Infect Dis Asunto de la revista: DOENCAS TRANSMISSIVEIS Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos