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Trial record 3 of 544 for:    VANCOMYCIN

Vancomycin in the Target Site Treatment of Intracranial Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03585426
Recruitment Status : Enrolling by invitation
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Tracking Information
First Submitted Date  ICMJE July 1, 2018
First Posted Date  ICMJE July 13, 2018
Last Update Posted Date July 13, 2018
Actual Study Start Date  ICMJE March 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2018)
Vancomycin concentration change in serum and cerebrospinal fluid [ Time Frame: 0.5h, 1h, 1.5h, 3h, 5h, 7h, 9h, and 12h after treatment ]
Quantitative analysis of vancomycin in serum and cerebrospinal fluid after treatment by an updated LC-MS/MS method.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vancomycin in the Target Site Treatment of Intracranial Infection
Official Title  ICMJE Vancomycin in the Target Site Treatment of Intracranial Infection : a New Strategy for PK/PD Treatment
Brief Summary Vancomycin, a novel intravenously administered antibiotic, currently plays a key role in the management of complicated multi-organism infections. However,current LC-MS/MS methods briefly describe parameters and the only reported internal standard was sometimes difficult to obtain. In our study,an updated LC-MS/MS method for the quantitative analysis of vancomycin in human serum was developed.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Vancomycin
Intervention  ICMJE Drug: Vancomycin
Vancomycin, a novel intravenously administered glycylcycline antibiotic, currently plays a key role in the management of complicated multi-organism infections.
Study Arms  ICMJE
  • Experimental: Vancomycin 1g q12h
    Intervention: Drug: Vancomycin
  • Experimental: Vancomycin 1g q8h
    Intervention: Drug: Vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 1, 2018)
2
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

In ICU; ventricle drainage was carried out; renal function is normal, namely creatinine clearance rate is >60ml/min;

Exclusion Criteria:

women in pregnancy or lactation;in patients with renal insufficiency, the creatinine clearance rate (Clcr) is less than 60ml/min.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03585426
Other Study ID Numbers  ICMJE XJYY-LL-FJ-045
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xijing Hospital
Study Sponsor  ICMJE Xijing Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yanyan Jia, Dr. The First Affiliated Hospital, the Fourth Military Medical University
PRS Account Xijing Hospital
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP