NCT01295801

Brief Summary

Linezolid is the first approved synthetic oxazolidinone that is active against multidrug-resistant Gram-positive pathogens. Because of its significant efficacy, linezolid is widely used in clinical treatment. However, the side effects of linezolid commonly lead to anemia and thrombocytopenia. This hematological toxic effects limit its prolonged used. The investigators have found that Vitamin B6 application, as a preventive, auxiliary therapy, can relieve anemia and thrombocytopenia. The present study was designed to verify the effects of Vitamin B6 in the prevention of linezolid-associated cytopenias and investigate its mechanism.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

November 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

February 15, 2011

Status Verified

October 1, 2010

Enrollment Period

8 months

First QC Date

February 14, 2011

Last Update Submit

February 14, 2011

Conditions

CytopeniasErythropenia (Diagnosis)

Keywords

LinezolidVitamin B6Linezolid-associated cytopenias

Study Arms (2)

Linezolid+vitamin B6

Linezolid

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Use of linezolid

You may qualify if:

  • Use of linezolid is not less than 3 days

You may not qualify if:

  • Serious adverse reactions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (1)

  • Deng J, Su LX, Liang ZX, Liang LL, Yan P, Jia YH, Zhang XG, Feng D, Xie LX. Effects of vitamin b6 therapy for sepsis patients with linezolid-associated cytopenias: a retrospective study. Curr Ther Res Clin Exp. 2013 Jun;74:26-32. doi: 10.1016/j.curtheres.2012.12.002.

    PMID: 24385027DERIVED

MeSH Terms

Conditions

CytopeniaDisease

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xie Lixin, Doctor

    Pneumology Department of chinese PLA General Hospital

    STUDY DIRECTOR

Central Study Contacts

Su Longxiang, Doctor

CONTACT

+86 13621086327

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2011

First Posted

February 15, 2011

Study Start

November 1, 2010

Primary Completion

July 1, 2011

Study Completion

September 1, 2011

Last Updated

February 15, 2011

Record last verified: 2010-10

Locations

CN(1)