Vitamin B6 on Relieving Linezolid-associated Cytopenias

Cytopenias Clinical Trial

Official title:

The Effects and Mechanism of Vitamin B6 on Relieving Linezolid-associated Cytopenias

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01295801
• Other study ID #: 301PLAGH-20101027001
• Status: Recruiting
• Phase: N/A
• First received: February 14, 2011
• Last updated: February 14, 2011
• Start date: November 2010
• Est. completion date: September 2011

Study information

• Verified date: October 2010
• Source: Chinese PLA General Hospital
• Contact: Su Longxiang, Doctor
• Phone: +86 13621086327
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Use of linezolid is not less than 3 days

Exclusion Criteria:

• Serious adverse reactions

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cytopenias
• Erythropenia (Diagnosis)

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China,