Tentative clinical breakpoints and epidemiological cut-off values of nemonoxacin for Streptococcus pneumoniae and Staphylococcus aureus isolates associated with community-acquired pneumonia.
J Glob Antimicrob Resist
; 23: 388-393, 2020 12.
Article
em En
| MEDLINE
| ID: mdl-33207229
ABSTRACT
OBJECTIVES:
To determine the minimum inhibitory concentration (MIC) distribution, epidemiological cut-off (ECOFF) values and clinical breakpoints (CBPs) of nemonoxacin, a non-fluorinated quinolone, for community-acquired pneumonia (CAP)-related Streptococcus pneumoniae and Staphylococcus aureus.METHODS:
We pooled the susceptibility and clinical data of CAP patients enrolled in five clinical trials conducted in three countries from 2006 to 2017. Published pharmacokinetic (PK) profiles of oral (500â¯mg) and intravenous (IV) (500, 650 and 750â¯mg) nemonoxacin formulations and pharmacodynamic (PD) parameters of the two aforementioned CAP-related Gram-positive cocci (GPC) were used to determine plausible CBPs. Moreover, nemonoxacin MIC distributions of CAP-relatedS. pneumoniae (nâ¯=â¯1800) and S. aureus (nâ¯=â¯2000) isolates were obtained to evaluate ECOFF values using a visual estimation approach and ECOFFinder.RESULTS:
More than 92% of patients with CAP caused byS. pneumoniae or S. aureus with nemonoxacin MICsâ¯≤â¯0.25â¯mg/L presented positive clinical and microbiological outcomes. The ECOFF, MIC90 and MIC99 values of nemonoxacin were, respectively, 0.06, 0.125 and 1â¯mg/L for S. pneumoniae and 0.125, 1 and 8â¯mg/L for S. aureus. Based on differences in the PK profiles of oral and IV formulations, PD parameters of nemonoxacin for these CAP-GPC and clinical in vivo efficacy data, tentative CBPs of 0.5, 0.5 and 1â¯mg/L, respectively, were established for the 500â¯mg oral and 500â¯mg and 750â¯mg IV nemonoxacin formulations for S. pneumoniae, and 0.25, 0.5 and 1â¯mg/L for S. aureus.CONCLUSION:
This study provides plausible nemonoxacin CBPs for two important CAP-GPC.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Pneumonia
/
Quinolonas
Tipo de estudo:
Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
J Glob Antimicrob Resist
Ano de publicação:
2020
Tipo de documento:
Article