PMID- 30423040 OWN - NLM STAT- MEDLINE DCOM- 20191107 LR - 20191107 IS - 1537-6591 (Electronic) IS - 1058-4838 (Linking) VI - 67 IP - suppl_2 DP - 2018 Nov 13 TI - A Prospective Multicenter Clinical Observational Study on Vancomycin Efficiency and Safety With Therapeutic Drug Monitoring. PG - S249-S255 LID - 10.1093/cid/ciy680 [doi] AB - BACKGROUND: Vancomycin is a first-line antibiotic used for the treatment of severe gram-positive bacterial infections. Clinical guidelines recommend that the vancomycin trough concentration be 10-15 mg/L for regular infections and 15-20 mg/L for severe infections. We investigated whether increasing the vancomycin concentration would result in better clinical outcomes with sustainable adverse effects (AEs) in the Chinese population. METHODS: A prospective, open, multicenter clinical observational study was performed in patients with gram-positive bacterial infections from 13 teaching hospitals. Patients received vancomycin therapeutic drug monitoring. Clinical, microbiological, and laboratory data were collected. RESULTS: In total, 510 patients were enrolled, and 470 were evaluable, of whom 370 were adults and 100 were children; 35.53% had methicillin-resistant Staphylococcus aureus infections (vancomycin 50% minimum inhibitory concentration [MIC50] = 1, 90% minimum inhibitory concentration [MIC90] = 1), and 23.19% had Enterococcus species infections (vancomycin MIC50 = 1, MIC90 = 2). The average trough concentration was 10.54 +/- 8.08 mg/L in adults and 6.74 +/- 8.93 mg/L in children. The infection was eradicated in 86.22% of adults and 96% of children. Thirty-six vancomycin-related nephrotoxicity cases were reported in the enrolled population. No severe AEs or deaths were related to vancomycin therapy. Logistic regression analysis showed that trough concentration had no relationship with clinical outcomes (adults P = .75, children P = .68) but was correlated with adult nephrotoxicity (P < .0001). Vancomycin trough concentration had an applicable cut point at 13 mg/L. CONCLUSIONS: Our study shows that vancomycin trough concentration has no statistical correlation with clinical outcomes, and is an indicator of nephrotoxicity in the observed population. We found no evidence that increasing vancomycin trough concentration to 15-20 mg/L can benefit Chinese patients with complicated infections. CLINICAL TRIALS REGISTRATION: ChiCTR-OPC-16007920. FAU - Liang, Xiaoyu AU - Liang X AD - Institute of Antibiotics, Huashan Hospital, Fudan University. AD - National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University. AD - Key Laboratory of Clinical Pharmacology of Antibiotics, National Health Commission of the People's Republic of China, Shanghai. FAU - Fan, Yaxing AU - Fan Y AD - Institute of Antibiotics, Huashan Hospital, Fudan University. AD - National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University. AD - Key Laboratory of Clinical Pharmacology of Antibiotics, National Health Commission of the People's Republic of China, Shanghai. FAU - Yang, Minjie AU - Yang M AD - Institute of Antibiotics, Huashan Hospital, Fudan University. FAU - Zhang, Jing AU - Zhang J AD - Institute of Antibiotics, Huashan Hospital, Fudan University. AD - National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University. AD - Key Laboratory of Clinical Pharmacology of Antibiotics, National Health Commission of the People's Republic of China, Shanghai. FAU - Wu, Jufang AU - Wu J AD - Institute of Antibiotics, Huashan Hospital, Fudan University. FAU - Yu, Jicheng AU - Yu J AD - Institute of Antibiotics, Huashan Hospital, Fudan University. FAU - Tao, Jinhao AU - Tao J AD - Department of Critical Care Medicine, Children's Hospital of Fudan University, Shanghai. FAU - Lu, Guoping AU - Lu G AD - Department of Critical Care Medicine, Children's Hospital of Fudan University, Shanghai. FAU - Zhang, Huifang AU - Zhang H AD - Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiaotong University. FAU - Wang, Ruilan AU - Wang R AD - Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiaotong University. FAU - Wen, Xiaoxing AU - Wen X AD - Department of Respiration, Zhongshan Hospital, Fudan University, Shanghai. FAU - Li, Huayin AU - Li H AD - Department of Respiration, Zhongshan Hospital, Fudan University, Shanghai. FAU - Zhang, Fengying AU - Zhang F AD - Department of Respiration, Putuo People's Hospital, Tongji University. FAU - Hang, Jingqin AU - Hang J AD - Department of Respiration, Putuo People's Hospital, Tongji University. FAU - Shen, Lihua AU - Shen L AD - Intensive Care Unit, Fudan University Shanghai Cancer Center. FAU - Zhang, Zhongwei AU - Zhang Z AD - Intensive Care Unit, Fudan University Shanghai Cancer Center. FAU - Lin, Qionghua AU - Lin Q AD - Intensive Care Unit, Fudan University Shanghai Cancer Center. FAU - Fu, Fengming AU - Fu F AD - Intensive Care Unit, Fudan University Shanghai Cancer Center. FAU - Wu, Shengbin AU - Wu S AD - Department of Nephrology, Shanghai Ninth People's Hospital. FAU - Shen, Bo AU - Shen B AD - Department of Nephrology, Shanghai Ninth People's Hospital. FAU - Huang, Weifeng AU - Huang W AD - Department of Critical Care Medicine, Shanghai Sixth People's Hospital, Shanghai Jiaotong University. FAU - Chang, Chunkang AU - Chang C AD - Department of Hematology, Shanghai Sixth People's Hospital, Shanghai Jiaotong University. FAU - Zhang, Hong AU - Zhang H AD - Clinical Laboratory, Children's Hospital of Shanghai Jiaotong University. FAU - Huang, Qiwei AU - Huang Q AD - Department of Neonatology, Children's Hospital of Shanghai Jiaotong University. FAU - Shi, Yifan AU - Shi Y AD - Department of Nephrology, Ruijin Hospital, Shanghai Jiaotong University. FAU - Ren, Hong AU - Ren H AD - Department of Nephrology, Ruijin Hospital, Shanghai Jiaotong University. FAU - Yuan, Qing AU - Yuan Q AD - Department of Respiration, Shanghai Tenth People's Hospital, Tongji University. FAU - Song, Xiaolian AU - Song X AD - Department of Respiration, Shanghai Tenth People's Hospital, Tongji University. FAU - Luo, Xuming AU - Luo X AD - Department of Respiration, Putuo Hospital, Shanghai University of Traditional Chinese Medicine. FAU - Zhang, Hong AU - Zhang H AD - Department of Pharmacy, Tongji Hospital, Tongji University, Shanghai, People's Republic of China. LA - eng SI - ChiCTR/ChiCTR-OPC-16007920 PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Research Support, Non-U.S. Gov't PL - United States TA - Clin Infect Dis JT - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JID - 9203213 RN - 0 (Anti-Bacterial Agents) RN - 6Q205EH1VU (Vancomycin) SB - IM MH - Adolescent MH - Aged MH - Anti-Bacterial Agents/*therapeutic use MH - Child MH - Child, Preschool MH - China MH - Dose-Response Relationship, Drug MH - *Drug Monitoring MH - Female MH - Gram-Positive Bacterial Infections/*drug therapy MH - Hospitals, Teaching MH - Humans MH - Infant MH - Infant, Newborn MH - Male MH - Middle Aged MH - Prospective Studies MH - Vancomycin/*therapeutic use EDAT- 2018/11/14 06:00 MHDA- 2019/11/08 06:00 CRDT- 2018/11/14 06:00 PHST- 2018/11/14 06:00 [entrez] PHST- 2018/11/14 06:00 [pubmed] PHST- 2019/11/08 06:00 [medline] AID - 5181264 [pii] AID - 10.1093/cid/ciy680 [doi] PST - ppublish SO - Clin Infect Dis. 2018 Nov 13;67(suppl_2):S249-S255. doi: 10.1093/cid/ciy680.