Vancomycin in the Target Site Treatment of Intracranial Infection

Phase 4

• Conditions: Vancomycin
• Interventions: Drug: Vancomycin

• Registration Number: NCT03585426
• Lead Sponsor: Xijing Hospital

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 available

Study Timeline

• Study Start: 2016-03
• Status Verified: 2018-06
• Study First Submitted: 2018-07-01
• Study First Submitted QC: 2018-07-01
• Last Update Submitted: 2018-07-01
• Study First Posted: 2018-07-13
• Last Update Posted: 2018-07-13
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin 1g q12h	Vancomycin	-
Vancomycin 1g q8h	Vancomycin	-

Primary Outcome Measures

Name	Time	Method
Vancomycin concentration change in serum and cerebrospinal fluid	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.