Pharmacokinetics/ Pharmacodynamics (PK/PD) Study of Vancomycin
Status:
Unknown status
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
1. Drug resistance of G+ cocci is a severe healthcare problem. According to the Ministry of
Health National Antimicrobial Resistant Investigation Net (mohnarin) surveillance
report, the isolation rate of MRSA is some 60% in China. MRSA infection has become a
serious clinical problem;
2. Vancomycin is a bactericidal glycopeptide antibiotic which inhibits bacterial growth by
hindering the synthesis of cell wall in bacteria. It exerts strong antibiotic effect to
Gram+ bacteria. It is indicated for serious staphylococcus infections especially MRSA
infection and has become the gold standard agent in MRSA treatment;
3. Vancomycin is a time-dependent antibiotic, its clinical and microbiological efficacy is
related to area under curve（ AUC）/minimum inhibitory concentration （MIC ）(AUIC). Cmin at
steady state is an surrogate parameter of AUIC, which is closely associated to the
efficacy;
4. AUIC >400 and Cmin between 15~20 mg/L are recommended for effective vancomycin treatment
by Infectious Diseases Society of America （IDSA） although it is still disputable;
5. Due to the absence of PK/PD study on vancomycin in China, administration of vancomycin
is performed in reference to the recommendation of IDSA. Its suitability to Chinese
patients is still to be clarified;
6. Plasma concentrations of vancomycin vary significantly between population and
individuals. Factors such as large-volume fluid infusion, hypoproteinemia and renal
clearance, etc. will influence the distribution and excretion of vancomycin, resulting
in different plasma concentrations between individuals. Results of PK studies differ
greatly between China and abroad. Administration based on the AUIC or Cmin recommended
by IDSA would not be suitable to Chinese patients. Given the definite long-term benefit
of vancomycin treatment, the AUIC or Cmin suitable to Chinese patients must be
identified by clinical study.
7. The PK/PD study on vancomycin in the treatment to MRSA septicemia and endocarditis is of
great significance for more reasonable use and improved therapeutic efficacy of MRSA
infection.
Phase:
Phase 4
Details
Lead Sponsor:
Zhejiang University
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University Guangzhou General Hospital of Guangzhou Military Command Qilu Hospital Qilu Hospital of Shandong University Second Affiliated Hospital, School of Medicine, Zhejiang University Shengjing Hospital The First Affiliated Hospital of Soochow University The First Affiliated Hospital with Nanjing Medical University Tianjin Medical University Cancer Institute and Hospital Zhejiang Provincial Hospital of TCM