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NCT03585426 Clinical Trial

Vancomycin in the Target Site Treatment of Intracranial Infection

Vancomycin Clinical Trial

Official title:
Vancomycin in the Target Site Treatment of Intracranial Infection : a New Strategy for PK/PD Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03585426
Other study ID # XJYY-LL-FJ-045
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date March 2016
Est. completion date December 2018

Study information
Verified date June 2018
Source Xijing Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 2
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Vancomycin
Vancomycin, a novel intravenously administered glycylcycline antibiotic, currently plays a key role in the management of complicated multi-organism infections.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Xijing Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Vancomycin concentration change in serum and cerebrospinal fluid Quantitative analysis of vancomycin in serum and cerebrospinal fluid after treatment by an updated LC-MS/MS method. 0.5h, 1h, 1.5h, 3h, 5h, 7h, 9h, and 12h after treatment
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