Vitamin B6 on Relieving Linezolid-associated Cytopenias | NCT01295801

Studies
Vitamin B6 on Relieving Linezolid-associated Cytopenias

NCT01295801

Sponsor

Chinese PLA General Hospital

Status

Unknown status

Last Update Posted

Feb 15, 2011Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Cytopenias
Erythropenia (Diagnosis)

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Jul 2011Estimated

Completion Date

Sep 2011Estimated

First Submitted Date

Feb 14, 2011

First Submission Date that Met QC Criteria

Feb 14, 2011

First Posted Date

Feb 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2011

Last Update Posted Date

Feb 15, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Infected patients receiving linezolid therapy are divided into two groups, i.e. the linezolid group and the linezolid + vitamin B6 group, the line of division being whether vitamin B6 is to be applied or not in the course of treatment. The purpose is to evaluate the role that vitamin B6 plays, during the process of linezolid therapy, in the relief of erythropenia and cytopenias.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Use of linezolid is not less than 3 days

Exclusion Criteria:

Serious adverse reactions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Use of linezolid

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Su Longxiang, Doctor	Contact	+86 13621086327

Overall Officials

Name	Affiliation	Role
Xie Lixin, Doctor	Pneumology Department of chinese PLA General Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chinese PLA General Hospital	Recruiting	Beijing	Beijing Municipality	100853	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24385027	Derived	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.

ID	Term
D000095542	Cytopenia
D004194	Disease

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms