NCT03585426UnknownPhase 4
Vancomycin in the Target Site Treatment of Intracranial Infection : a New Strategy for PK/PD Treatment
Xijing Hospital0 sites2 target enrollmentStarted: March 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 2
- Primary Endpoint
- Vancomycin concentration change in serum and cerebrospinal fluid
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Vancomycin 1g q12h
Experimental
Intervention: Vancomycin (Drug)
Vancomycin 1g q8h
Experimental
Intervention: Vancomycin (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Similar Trials
Unknown
Not Applicable
Therapeutic Monitoring of Vancomycin in Critical Ill Patients: a RegistryCritically IllNCT02896218Peking University Third Hospital400
Completed
Not Applicable
Optimization of intravenous vancomycin treatment schedule for pediatric population with Monte Carlo SimulatioPatients under 18 years old who were administered intravenous vancomycin in Department of Pediatrics or Department of Pediatric Cardiology in our institute between April 1st 2011 and March 31st 2016.JPRN-UMIN000022343Department of Pediatrics, Yokohama City University100
Terminated
Not Applicable
Use of a Loading Dose of Vancomycin in Pediatric DosingInfectionNCT01290237Boston Children's Hospital59
Completed
Not Applicable
Economic Evaluation of Vancomycin Therapeutic Drug Monitoring MethodsInfection, BacterialNCT04297176Hamad Medical Corporation65
Terminated
Phase 4
Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU PatientsMRSA - Methicillin Resistant Staphylococcus Aureus InfectionNCT01786161Massachusetts General Hospital44