Vitamin B6 on Relieving Linezolid-associated Cytopenias

• Conditions: Cytopenias; Erythropenia (Diagnosis)

• Registration Number: NCT01295801
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Status Verified: 2010-10
• Study Start: 2010-11
• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-14
• Last Update Submitted: 2011-02-14
• Study First Posted: 2011-02-15
• Last Update Posted: 2011-02-15
• Primary Completion: 2011-07
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Use of linezolid is not less than 3 days

Exclusion Criteria

• Serious adverse reactions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China