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Trial record 2 of 100 for:    endocarditis AND Bacterial Infections

Pharmacokinetics/ Pharmacodynamics (PK/PD) Study of Vancomycin

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ClinicalTrials.gov Identifier: NCT02443064
Recruitment Status : Unknown
Verified May 2015 by Yong-Hong Xiao, Zhejiang University.
Recruitment status was:  Recruiting
First Posted : May 13, 2015
Last Update Posted : May 13, 2015
Sponsor:
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
Information provided by (Responsible Party):
Yong-Hong Xiao, Zhejiang University

Brief 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.

Condition or disease Intervention/treatment Phase
Blood Stream Infections Endocarditis MRSA Drug: Vancomycin Phase 4

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics/ Pharmacodynamics (PK/PD) Study of Vancomycin in the Treatment of Methicillin-resistant Staphylococcus Aureus(MRSA) Blood Stream Infection (Septicemia) and Endocarditis in Chinese Patients
Study Start Date : January 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis MRSA

Arm Intervention/treatment
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

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.





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. Number of participants with adverse events [ Time Frame: Participants will be followed during vancomycin treatment and in average of 4 weeks after vancomycin treatment ]
  3. Number of participants survival [ Time Frame: Participants will be followed during vancomycin treatment and in average of 4 weeks after vancomycin treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443064


Contacts
Contact: Yong-hong Xiao, MD +86-571-87236421 xiao-yonghong@163.com

Locations
China, Zhejiang
Yong-Hong Xiao Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Yong-Hong Xiao, MD    +86-571-87236421    xiao-yonghong@163.com   
Sponsors and Collaborators
Zhejiang University
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
Investigators
Principal Investigator: Yong-hong Xiao, MD The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China

Publications of Results:
Other Publications:
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
ClinicalTrials.gov Identifier: NCT02443064     History of Changes
Other Study ID Numbers: XYH-88
zju-vancamycin ( Other Identifier: zju-vancamycin )
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015

Keywords provided by Yong-Hong Xiao, Zhejiang University:
Pharmacokinetics/pharmacodynamics
vancomycin
blood stream infections
Chinese patients
MRSA

Additional relevant MeSH terms:
Infection
Endocarditis
Heart Diseases
Cardiovascular Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents