Monotherapy vs. combination therapy for Enterococcus faecalis bacteraemia: a target trial emulation.
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История · было → стало
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Bartoletti Michele, Rosselli Del Turco Elena, Bussini Linda, Paul Mical, Sabik Eman Fares, Castagna Antonella, Ripa Marco, Gomes Marisa Z R, Di Bella Stefano, Malosso Marta, Lopez Alicia Beteta, Franceschini Erica, Bandera Alessandra, Barbieri Viviana, Oliva Alessandra, Munoz Patricia, Mularoni Alessandra, Seminari Elena, Morelli Paola, Tascini Carlo, Papadimitriou-Olivgeris Matthaios, Coppola Nicola, Cristini Francesco, Russo Alessandro, Bassetti Matteo, Travi Giovanna, Lopez Contreras Joaquin, Varisco Benedetta, Viale Pierluigi, Cento Valeria, Gaibani Paolo, Bavaro Davide Fiore, Giannella Maddalena, ESCMID Study Group of Bloodstream Infection, Endocarditis and Sepsis (ESGBIES)
Аннотация
METHODS: This was a target trial emulation based on a prospective, multicentre, international dataset collected in 24 international centres from January 2019 to December 2024. We included all adult patients with monomicrobial EF-BSI with negative echocardiography within 7 days from BSI onset. Exclusion criteria were diagnosis of endocarditis, not receiving or completed the therapy at randomization. Primary endpoint was clinical failure defined as a composite of death, relapse of EF-BSI, and diagnosis of endocarditis, at 90 days.
RESULTS: Overall, 373 patients were eligible for inclusion, 267 of whom (71%) received monotherapy, mainly ampicillin (174 of 267, 65%); most prescribed combination regimens were ampicillin with either ceftriaxone or gentamicin (80 of 106, 75%). The composite clinical failure was met by 114 of 373 (31%) patients. The outcomes among patients who received monotherapy or combination treatment were 75 of 267 (28%) versus 39 of 106 (36%); p 0.185, leading to an overall risk difference in favour of monotherapy of 2% (95% CI, -10% to 15%). Sepsis or septic shock at the time of presentation was the only independent variables associated with clinical failure, after performing a weighted univariable and multivariable Cox regression model (adjusted hazard ratio, 0.85; 95% CI, 0.52-1.39).
CONCLUSIONS: With the limitation of our sample size and observational design, we were not able to observe a better outcome associated with combination treatment for EF-BSI. If confirmed, these results would promote therapeutic simplification according to antimicrobial stewardship principles.