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Vitamin B6 on Relieving Linezolid-associated Cytopenias

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01295801
Collaborator
(none)
80
Enrollment
1
Location
10
Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Effects and Mechanism of Vitamin B6 on Relieving Linezolid-associated Cytopenias
    Study Start Date :
    Nov 1, 2010
    Anticipated Primary Completion Date :
    Jul 1, 2011
    Anticipated Study Completion Date :
    Sep 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Linezolid+vitamin B6
    Linezolid

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Use of linezolid is not less than 3 days
      Exclusion Criteria:
      • Serious adverse reactions

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Chinese PLA General Hospital Beijing Beijing China 100853

      Sponsors and Collaborators

      • Chinese PLA General Hospital

      Investigators

      • Study Director: Xie Lixin, Doctor, Pneumology Department of chinese PLA General Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01295801
      Other Study ID Numbers:
      • 301PLAGH-20101027001
      First Posted:
      Feb 15, 2011
      Last Update Posted:
      Feb 15, 2011
      Last Verified:
      Oct 1, 2010
      Keywords provided by , ,
      Linezolid
      Vitamin B6
      Linezolid-associated cytopenias
      Additional relevant MeSH terms:
      Anemia
      Leukopenia
      Thrombocytopenia

      Study Results

      No Results Posted as of Feb 15, 2011