Status unknownNCT02443064Updated May 13, 2015

Pharmacokinetics/ Pharmacodynamics (PK/PD) Study of Vancomycin

A Phase 4 interventional study of Vancomycin in Blood Stream Infections, Endocarditis and MRSA, sponsored by Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-13.

Sponsored by Zhejiang University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 4
Study type: Interventional
Enrollment: 100
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

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;
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;
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;
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;
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;
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.
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.

Read the detailed description

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

Conditions studied

Blood Stream Infections
Endocarditis
MRSA

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Keywords

Pharmacokinetics/pharmacodynamics
vancomycin
blood stream infections
Chinese patients
MRSA

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 100 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age ≥18 years, male or female;
diagnosed as MRSA septicemia or endocarditis; Septicemia clinical manifestations of infection; MRSA infection confirmed by blood culture; Endocarditis: diagnosed according to modified Duke Criteria
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

Exclusion Criteria:

those being allergic to glycopeptides antibiotics;
those with osteomyelitis, central nervous system infection or other septic migrations (except for endocarditis);
patients with catheter-related bloodstream infection who cannot withdraw catheter;
those during chemotherapy for cancer or leukemia;
those with agranulocytosis;
those with HIV infection;
women in pregnancy or lactation;
patients receiving vancomycin for less than 72 hours;
patients participating in any other clinical trial in 3 months prior to the study (not limited to trials for antibiotics)

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 100 participants (estimated)

Study arms

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: Vancomycin

Interventions

DrugVancomycin
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.

What researchers measure

Primary outcomes

AUC/MIC of vancomycin in each patient
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Secondary outcomes

Number of participants with negative blood culture at the end of treatment
Time frame: Participants will be followed during vancomycin treatment and in average of 4 weeks after vancomycin treatment
Number of participants with adverse events
Time frame: Participants will be followed during vancomycin treatment and in average of 4 weeks after vancomycin treatment
Number of participants survival
Time frame: Participants will be followed during vancomycin treatment and in average of 4 weeks after vancomycin treatment

Study locations

1 of 1 sites recruiting

Yong-Hong Xiao
Hangzhou, Zhejiang 310003, China
- Yong-Hong Xiao, MD · Contact · xiao-yonghong@163.com · +86-571-87236421
Recruiting

References and documents

Publications

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. PubMed 21460309 ↗
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. PubMed 22123681 ↗
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. Erratum In: Clin Infect Dis. 2011 Aug 1;53(3):319. PubMed 21208910 ↗
Anonymous. Expert consensus on the use of vancomycin(2011). Chin J of New Drug & Regimen. 2011，30（8）：561-56
1.Xiao YH, et al. 2010 report of Mohnarin. Chin J Nosocomial Infect. 2012, 22(22):4946-4952
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. PubMed 15509186 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02443064
Lead sponsor: Zhejiang University
Collaborators: Shengjing Hospital, Tianjin Medical University Cancer Institute and Hospital, Qilu Hospital of Shandong University, First Affiliated Hospital, Sun Yat-Sen University, Guangzhou General Hospital of Guangzhou Military Command, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital with Nanjing Medical University, Zhejiang Provincial Hospital of TCM, Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party: Yong-Hong Xiao (Vice Director, China State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou., Zhejiang University) — Principal investigator
First posted: May 13, 2015
Start date: Jan 2014
Primary completion: Jan 2016 (estimated)
Completion: Jun 2016 (estimated)
Last update: May 13, 2015

Study contacts

Yong-hong Xiao, MD

Contact

xiao-yonghong@163.com

+86-571-87236421

Yong-hong Xiao, MD

principal investigator · The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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