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Safety of ceftobiprole in patients with impaired renal, hepatic or immune function: A multinational retrospective hospital chart review (RETRACE study)

  • Título: Safety of ceftobiprole in patients with impaired renal, hepatic or immune function: A multinational retrospective hospital chart review (RETRACE study)
  • Autores: de Novales, FJM; Falcone, M; Soriano, A; Fernández-Hidalgo, N; Francisci, D; Gentile, I; Cedar, E; Jemmely, N; Quevedo, J; Estebanez, M; Durante-Mangoni, E; RETRACE Study Grp
  • Revista: INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS
  • IF: 4,6
  • Quartil: Q1
  • DOI: 10.1016/j.ijantimicag.2025.107450
  • Centro: Hospital Universitario La Moraleja
  • Departamento/servicio: Medicina Interna

Abstract:

Background and Aim: Ceftobiprole, an advanced-generation cephalosporin with broad bactericidal activity, is approved for community-acquired and hospital-acquired pneumonia (excluding ventilator-associated pneumonia). We aimed to evaluate, in a real-world setting, the safety profile of ceftobiprole in patients with risk conditions (severe renal impairment, hepatic impairment, and immunocompromised status), groups excluded from clinical trials. Methods: In this retrospective study (NCT04170309), 396 consecutive charts of patients treated with ceftobiprole during 2016-2022 in 15 centres in France, Italy, and Spain were analysed: 62 had severe renal impairment, 51 had a hepatic impairment, 120 were immunocompromised, and 203 had no predefined risk condition (controls).Results: Ceftobiprole was used for off-label indications in 110/396 (27.8%) patients; 46/396 (11.6%) patients received a higher-than-recommended dose. Treatment-emergent adverse events (TEAEs) considered as ceftobiprole-related occurred in 44 patients, more frequently in the risk groups compared to controls (severe renal impairment: 8/62 [12.9%]; hepatic impairment: 7/51 [13.7%]; immunocompromised: 19/120 [15.8%]; controls: 15/203, [7.4%]); in 7/44 patients, these events were serious. Compared to controls, liverrelated AEs occurred more frequently in the impaired hepatic function (17/51 [33.3%] vs. 22/203 [10.8%], odds ratio [OR:]: 4.11; 95% confidence interval [CI]: 1.98-8.55) and immunocompromised (30/120 [25.0%] vs. 22/203 [10.8%], OR: 2.74; 95% CI: 1.50-5.02) groups. Hyponatremia was also more frequent in immunocompromised patients than controls (14/120 [11.7%] vs. 9/203 [4.4%], OR: 2.85; 95% CI: 1.19-6.80). Underlying disease, concomitant medications and the poor health status of the patients likely affected these imbalances. Conclusion: Overall, no new safety concerns related to ceftobiprole use in real-world patients with severe renal impairment, hepatic impairment or immunocompromised status were identified. (Summary); Fernández-Hidalgo, N (corresponding author), Hosp Univ Vall Hebron, Vall Hebron Inst Recerca VHIR, Serv Malalties Infeccioses, Vall Hebron Campus Hosp, Passeig Vall Hebron 119-129, Barcelona 08035, Spain. (Author of contact)

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