Pharmacokinetics/ Pharmacodynamics (PK/PD) Study of Vancomycin
关键词
抽象
描述
Study design:
A multi-center, non-controlled, open-labeled observational study
Research objectives
Primary objective:
To explore the PK/PD target value (AUIC) of vancomycin in the treatment of MRSA septicemia and endocarditis in Chinese patients.
Secondary objective:
To detect the therapeutic efficacy and safety of vancomycin in the treatment of MRSA septicemia and endocarditis in Chinese patients.
To exam the relationship between the Cmin of vancomycin and its efficacy in the treatment to MRSA septicemia and endocarditis.
To explore the relationship between MRSA molecular type and vancomycin therapeutic efficacy
Medicine and administration
Drug:
Vancomycin
Dosing:
15~20 mg/kg, IV, q 12~8h (or 1 g, IV, q12~8h) for adult patient with normal renal function; Dosage should be adjusted by blood creatinine clearance in patients with impaired renal function; Administration route： 1~2 h/ dosing, IV
Drug combination:
Drug combination is not recommended for patients with simple MRSA infection; Rifampicin can be combined in case of MRSA artificial valve endocarditis; Anti-G- antibacterial agents can be combined in case of concurrent G- bacterial infections.
Duration:
Septicemia: 2~4 weeks Endocarditis: 6~8 weeks
日期
| 最后验证: | 04/30/2015 |
| 首次提交: | 11/22/2014 |
| 提交的预估入学人数: | 05/07/2015 |
| 首次发布: | 05/12/2015 |
| 上次提交的更新: | 05/07/2015 |
| 最近更新发布: | 05/12/2015 |
| 实际学习开始日期: | 12/31/2013 |
| 预计主要完成日期: | 12/31/2015 |
| 预计完成日期: | 05/31/2016 |
状况或疾病
干预/治疗
Drug: MRSA blood stream infection patient
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: MRSA blood stream infection patient Intervention:Vancomycin
Dosing:
15-20mg/kg, IV,q 12~8h (or 1 g, IV, q12~8h) for adult patient with normal renal function; Dosage should be adjusted by blood creatinine clearance in patients with impaired renal function; Administration route： 1~2 h/ dosing, IV
Drug combination:
Drug combination is not recommended for patients with simple MRSA infection; Rifampicin can be combined in case of MRSA artificial valve endocarditis; Anti-G- antibacterial agents can be combined in case of concurrent G- bacterial infections.
Duration:
Septicemia: 2~4 weeks Endocarditis: 6~8 weeks | Drug: MRSA blood stream infection patient Vancomycin was administered for Chinese patients with MRSA blood stream infection and endocarditis Pharmacokinetics: 5 blood samples collected at steady state for the determination of plasma concentrations for population pharmacokinetics (PPK) analysis.
Microbiology: blood cultures for MRSA isolation, MIC of vancomycin against MRSA; molecular typing will be analyzed on bacterial strains including heterogeneous vancomycin-intermediate Staphylococcus aureus (hVISA) and vancomycin-intermediate Staphylococcus aureus （VISA); Safety evaluation: hepatic and renal function, blood routine test, and so on. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. Age ≥18 years, male or female; 2. diagnosed as MRSA septicemia or endocarditis; Septicemia clinical manifestations of infection; MRSA infection confirmed by blood culture; Endocarditis: diagnosed according to modified Duke Criteria 3. no therapy with effective anti-MRSA drugs 72 hours prior to the study; Effective anti-MRSA drugs used in China include: vancomycin, norvancomycin, teicoplanin, linezolid, daptomycin, tigecycline, and fusidic acid. Exclusion Criteria: 1. those being allergic to glycopeptides antibiotics; 2. those with osteomyelitis, central nervous system infection or other septic migrations (except for endocarditis); 3. patients with catheter-related bloodstream infection who cannot withdraw catheter; 4. those during chemotherapy for cancer or leukemia; 5. those with agranulocytosis; 6. those with HIV infection; 7. women in pregnancy or lactation; 8. patients receiving vancomycin for less than 72 hours; 9. patients participating in any other clinical trial in 3 months prior to the study (not limited to trials for antibiotics) |
结果
主要结果指标
1. AUC/MIC of vancomycin in each patient [Participants will be followed for the duration of hospital stay, an expected average of 4 weeks]
次要成果指标
1. Number of participants with negative blood culture at the end of treatment [Participants will be followed during vancomycin treatment and in average of 4 weeks after vancomycin treatment]
2. Number of participants with adverse events [Participants will be followed during vancomycin treatment and in average of 4 weeks after vancomycin treatment]
3. Number of participants survival [Participants will be followed during vancomycin treatment and in average of 4 weeks after vancomycin treatment]
