NCT03585426

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2016

Typical duration for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 13, 2018

Status Verified

June 1, 2018

Enrollment Period

2.8 years

First QC Date

July 1, 2018

Last Update Submit

July 1, 2018

Conditions

Vancomycin

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Vancomycin 1g q12h

EXPERIMENTAL
Drug: Vancomycin

Vancomycin 1g q8h

EXPERIMENTAL
Drug: Vancomycin

Interventions

VancomycinDRUG

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

Vancomycin 1g q12hVancomycin 1g q8h

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Yanyan Jia, Dr.

    The First Affiliated Hospital, the Fourth Military Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2018

First Posted

July 13, 2018

Study Start

March 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

July 13, 2018

Record last verified: 2018-06