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| ID | Type | Description | Link |
|---|---|---|---|
| zju-vancamycin | Other Identifier | zju-vancamycin |
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| Name | Class |
|---|---|
| Shengjing Hospital | OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRSA blood stream infection patient | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC/MIC of vancomycin in each patient | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Number of participants with adverse events | Participants will be followed during vancomycin treatment and in average of 4 weeks after vancomycin treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong-hong Xiao, MD | Contact | +86-571-87236421 | xiao-yonghong@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yong-hong Xiao, MD | The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yong-Hong Xiao | Recruiting | Hangzhou | Zhejiang | 310003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21460309 | Background | Kullar R, Davis SL, Levine DP, Rybak MJ. Impact of vancomycin exposure on outcomes in patients with methicillin-resistant Staphylococcus aureus bacteremia: support for consensus guidelines suggested targets. Clin Infect Dis. 2011 Apr 15;52(8):975-81. doi: 10.1093/cid/cir124. | |
| 22123681 | Background | Brown J, Brown K, Forrest A. Vancomycin AUC24/MIC ratio in patients with complicated bacteremia and infective endocarditis due to methicillin-resistant Staphylococcus aureus and its association with attributable mortality during hospitalization. Antimicrob Agents Chemother. 2012 Feb;56(2):634-8. doi: 10.1128/AAC.05609-11. Epub 2011 Nov 28. |
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| ID | Term |
|---|---|
| D004696 | Endocarditis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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| OTHER |
| Guangzhou General Hospital of Guangzhou Military Command | OTHER |
| The First Affiliated Hospital of Soochow University | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Zhejiang Provincial Hospital of TCM | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
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| Number of participants survival | Participants will be followed during vancomycin treatment and in average of 4 weeks after vancomycin treatment |
| 21208910 | Background | Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, Kaplan SL, Karchmer AW, Levine DP, Murray BE, J Rybak M, Talan DA, Chambers HF; Infectious Diseases Society of America. Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011 Feb 1;52(3):e18-55. doi: 10.1093/cid/ciq146. Epub 2011 Jan 4. |
| Background | Anonymous. Expert consensus on the use of vancomycin(2011). Chin J of New Drug & Regimen. 2011,30(8):561-56 |
| Result | 1.Xiao YH, et al. 2010 report of Mohnarin. Chin J Nosocomial Infect. 2012, 22(22):4946-4952 |
| 15509186 | Result | Moise-Broder PA, Forrest A, Birmingham MC, Schentag JJ. Pharmacodynamics of vancomycin and other antimicrobials in patients with Staphylococcus aureus lower respiratory tract infections. Clin Pharmacokinet. 2004;43(13):925-42. doi: 10.2165/00003088-200443130-00005. |
| D000602 |
| Amino Acids, Peptides, and Proteins |