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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 : Unknown
Verified June 2018 by Xijing Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vancomycin Drug: Vancomycin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Vancomycin in the Target Site Treatment of Intracranial Infection : a New Strategy for PK/PD Treatment
Actual Study Start Date : March 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Vancomycin 1g q12h Drug: Vancomycin
Vancomycin, a novel intravenously administered glycylcycline antibiotic, currently plays a key role in the management of complicated multi-organism infections.
Experimental: Vancomycin 1g q8h Drug: Vancomycin
Vancomycin, a novel intravenously administered glycylcycline antibiotic, currently plays a key role in the management of complicated multi-organism infections.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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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): NCT03585426


Sponsors and Collaborators
Xijing Hospital
Investigators
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Study Director: Yanyan Jia, Dr. The First Affiliated Hospital, the Fourth Military Medical University
More Information
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03585426    
Other Study ID Numbers: XJYY-LL-FJ-045
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents