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Clin Infect Dis. 2018 Nov 13;67(suppl_2):S256-S262. doi: 10.1093/cid/ciy667.

Model-based Evaluation of the Clinical and Microbiological Efficacy of Vancomycin: A Prospective Study of Chinese Adult In-house Patients.

Shen K1,2,3, Yang M1,2, Fan Y1,2, Liang X1,2, Chen Y1,2, Wu J1,2, Yu J1,2, Zhang H4, Wang R4, Zhang F5, Hang J5, Wen X6, Li H6, Shen L7, Zhang Z7, Wu S6, Shen B8, Huang W9, Chang C10, Shen Y11, Ren H11, Yuan Q12, Song X12, Luo X13, Zhang H14, Yang W15, Yang J15, Zhang J1,2,3.

Author information

1
Institute of Antibiotics, Huashan Hospital, Fudan University.
2
National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University.
3
Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission of People's Republic of China.
4
Department of Critical Care Medicine, Shanghai General Hospital of Fudan University.
5
Department of Respiration, Putuo Hospital, Tongji University.
6
Department of Respiration, Zhongshan Hospital.
7
Intensive Care Unit, Shanghai Tumor Hospital, Fudan University.
8
Department of Nephrology, Shanghai Ninth People's Hospital.
9
Department of Critical Care Medicine, Shanghai Sixth People's Hospital.
10
Department of Hematology, Shanghai Sixth People's Hospital.
11
Department of Nephrology, Ruijin Hospital, Shanghai Jiaotong University.
12
Department of Respiration, Shanghai Tenth Hospital, Tongji University.
13
Department of Respiration, Putuo Hospital, Shanghai University of Traditional Chinese Medicine.
14
Department of Pharmacy, Tongji Hospital, Tongji University.
15
Mosim Co., Ltd, People's Republic of China.

Abstract

Background:

Our aims in this prospective study were to evaluate the correlations between pharmacokinetic/pharmacodynamic (PK/PD) indices and the clinical/microbiological efficacy of vancomycin and to identify an appropriate PK/PD target in the Chinese population to guide vancomycin treatment in the clinic.

Methods:

Adult patients from 11 hospitals in China with gram-positive infections who received vancomycin therapy for ≥5 days and who were under therapeutic drug monitoring (TDM) were enrolled in this study. A 1-compartment population PK model was established and validated. The correlations between PK/PD indices (Cmin, Cmax, 0-24 hour area under the curve (AUC0-24), and AUC0-24/minimum inhibitory concentration (MIC) and clinical outcomes (clinical efficacy and bacterial eradication) were evaluated.

Results:

In total, 402 adult Chinese patients were enrolled. Among them, 380 patients were evaluable for PK analysis, and 334 were evaluable for PK/PD analysis. In the final population PK model, creatinine clearance (CLCR) was the significant covariate on CL (typical value, 3.87 L/hour; between-subject variability (BSV), 12.5%), and age was the significant covariate on volume of distribution (V) (typical value, 45.1 L; BSV, 24.8%). The univariate analysis showed that Cmax, AUC0-24, and AUC0-24/MIC were significantly different or marginally significantly different (P values were 0.009, 0.0385, and 0.0509, respectively) between microbiological outcome groups with coagulase-negative Staphylococcus infections. However, there were no significant differences (P > .05) in the above PK parameters by multivariate logistic regression analysis, indicating there was no independently associated factor.

Conclusions:

No significant correlations were identified between PK/PD indices and the clinical or microbiological efficacy of vancomycin in Chinese patients. The necessity of vancomycin TDM based on trough concentration and the current treatment target of AUC0-24/MIC ≥400 need to be further evaluated and confirmed in additional prospective studies.

PMID:
30423042
DOI:
10.1093/cid/ciy667

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