CEFTO-CURE study: CEFTObiprole Clinical Use in Real-lifE - a multi-centre experience in Italy.


Journal

International journal of antimicrobial agents
ISSN: 1872-7913
Titre abrégé: Int J Antimicrob Agents
Pays: Netherlands
ID NLM: 9111860

Informations de publication

Date de publication:
Jul 2023
Historique:
received: 05 10 2022
revised: 03 04 2023
accepted: 07 04 2023
medline: 19 6 2023
pubmed: 16 4 2023
entrez: 15 4 2023
Statut: ppublish

Résumé

Ceftobiprole is approved in Europe for treatment of community-acquired pneumonia and non-ventilator-associated hospital-acquired pneumonia (HAP) in adults. Real-world data are limited. This multi-centre, observational, ambispective investigator-initiated study was undertaken in Italy from January 2018 to December 2019 in order to evaluate the use of ceftobiprole in a real-world setting. Overall, 195 patients from 10 centres were evaluated (68% retrospectively). Male sex was prevalent (n=121, 62%). Median age was 67 [interquartile range (IQR) 53-75] years. Median Charlson Comorbidity Index score was 5 (IQR 3-7). The most common indication was pneumonia (151/195, 77%), especially HAP. Other uses were skin and soft tissue infections (5%), endocarditis (4%) and bone infections (4%). Ceftobiprole was usually an empiric choice (65%), in combination with other drugs (66%) and as second-line therapy (58%). A causative agent was found in 39% of cases. A diagnosis of sepsis was made in 59 cases (30%). Success in the clinically evaluable population (excluding 12 cases due to isolation of pathogens outside ceftobiprole's spectrum of activity) was obtained in 79% of cases, with all-cause mortality of 20%. On multi-level analysis, three predictors were positively associated with clinical success: male gender, pneumonia and detection of causal agent. Sepsis was a negative predictor. Nine factors were independently associated, favourably or unfavourably, with fatal outcome. Ceftobiprole is a safe and effective therapeutic choice, even in a real-world setting. More data are needed to establish its efficacy in patients with sepsis.

Sections du résumé

BACKGROUND BACKGROUND
Ceftobiprole is approved in Europe for treatment of community-acquired pneumonia and non-ventilator-associated hospital-acquired pneumonia (HAP) in adults. Real-world data are limited.
METHODS METHODS
This multi-centre, observational, ambispective investigator-initiated study was undertaken in Italy from January 2018 to December 2019 in order to evaluate the use of ceftobiprole in a real-world setting.
RESULTS RESULTS
Overall, 195 patients from 10 centres were evaluated (68% retrospectively). Male sex was prevalent (n=121, 62%). Median age was 67 [interquartile range (IQR) 53-75] years. Median Charlson Comorbidity Index score was 5 (IQR 3-7). The most common indication was pneumonia (151/195, 77%), especially HAP. Other uses were skin and soft tissue infections (5%), endocarditis (4%) and bone infections (4%). Ceftobiprole was usually an empiric choice (65%), in combination with other drugs (66%) and as second-line therapy (58%). A causative agent was found in 39% of cases. A diagnosis of sepsis was made in 59 cases (30%). Success in the clinically evaluable population (excluding 12 cases due to isolation of pathogens outside ceftobiprole's spectrum of activity) was obtained in 79% of cases, with all-cause mortality of 20%. On multi-level analysis, three predictors were positively associated with clinical success: male gender, pneumonia and detection of causal agent. Sepsis was a negative predictor. Nine factors were independently associated, favourably or unfavourably, with fatal outcome.
CONCLUSIONS CONCLUSIONS
Ceftobiprole is a safe and effective therapeutic choice, even in a real-world setting. More data are needed to establish its efficacy in patients with sepsis.

Identifiants

pubmed: 37061102
pii: S0924-8579(23)00096-1
doi: 10.1016/j.ijantimicag.2023.106817
pii:
doi:

Substances chimiques

ceftobiprole 5T97333YZK
Anti-Bacterial Agents 0
Cephalosporins 0

Types de publication

Multicenter Study Observational Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

106817

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.

Auteurs

Ivan Gentile (I)

Section of Infectious Diseases, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy. Electronic address: ivan.gentile@unina.it.

Antonio Riccardo Buonomo (AR)

Section of Infectious Diseases, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.

Silvia Corcione (S)

Department of Medical Sciences, Infectious Diseases, University of Turin, Turin, Italy.

Laurenza Paradiso (L)

Ninth Division of Infectious Diseases, Cotugno Hospital, Azienda Ospedaliera dei Colli, Naples, Italy; Department of Precision Medicine, University of Campania 'L. Vanvitelli' and AORN Ospedali dei Colli-Monaldi Hospital, Naples, Italy.

Daniele Roberto Giacobbe (DR)

Department of Health Sciences, University of Genoa, Genoa, Italy; Clinica Malattie Infettive, Ospedale Policlinico San Martino, IRCCS, Genoa, Italy.

Davide Fiore Bavaro (DF)

Clinic of Infectious Diseases, University of Bari, University Hospital Policlinico, Bari, Italy.

Giusy Tiseo (G)

Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Francesca Sordella (F)

Infectious Diseases Unit, Azienda Ospedaliera S. Croce e Carle, Cuneo, Italy.

Michele Bartoletti (M)

Infectious Diseases Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Giulia Palmiero (G)

Fourth Division of Infectious Diseases, Cotugno Hospital, Azienda Ospedaliera dei Colli, Naples, Italy.

Antonietta Vozza (A)

Division of Pharmacy, AOU Federico II, Naples, Italy.

Antonio Vena (A)

Department of Health Sciences, University of Genoa, Genoa, Italy; Clinica Malattie Infettive, Ospedale Policlinico San Martino, IRCCS, Genoa, Italy.

Francesca Canta (F)

Department of Medical Sciences, Infectious Diseases, University of Turin, Turin, Italy.

Nicola Schiano Moriello (NS)

Section of Infectious Diseases, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.

Paola Congera (P)

Section of Infectious Diseases, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.

Arta Karruli (A)

Department of Precision Medicine, University of Campania 'L. Vanvitelli' and AORN Ospedali dei Colli-Monaldi Hospital, Naples, Italy.

Carlo Tascini (C)

Division of Infectious Diseases, University Hospital ASUFC, Udine, Italy.

Pierluigi Viale (P)

Infectious Diseases Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Valerio Del Bono (VD)

Infectious Diseases Unit, Azienda Ospedaliera S. Croce e Carle, Cuneo, Italy.

Marco Falcone (M)

Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Sergio Carbonara (S)

Infectious Diseases Unit, V. Emanuele II Hospital, Bisceglie, Italy.

Malgorzata Karolina Mikulska (MK)

Infectious Diseases Unit, Department of Health Sciences, University of Genoa, Genoa, Italy; Infectious Diseases Unit, Ospedale Policlinico San Martino, IRCCS for Oncology and Neurosciences, Genoa, Italy.

Matteo Bassetti (M)

Department of Health Sciences, University of Genoa, Genoa, Italy; Clinica Malattie Infettive, Ospedale Policlinico San Martino, IRCCS, Genoa, Italy.

Emanuele Durante-Mangoni (E)

Department of Precision Medicine, University of Campania 'L. Vanvitelli' and AORN Ospedali dei Colli-Monaldi Hospital, Naples, Italy.

Francesco Giuseppe De Rosa (FG)

Department of Medical Sciences, Infectious Diseases, University of Turin, Turin, Italy.

Alberto Enrico Maraolo (AE)

First Division of Infectious Diseases, Cotugno Hospital, Azienda Ospedaliera dei Colli, Naples, Italy.

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