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Vitamin B6 on Relieving Linezolid-associated Cytopenias

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ClinicalTrials.gov Identifier: NCT01295801
Recruitment Status : Unknown
Verified October 2010 by Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : February 15, 2011
Last Update Posted : February 15, 2011
Sponsor:
Information provided by:
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.

Condition or disease
Cytopenias Erythropenia (Diagnosis)

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 Type : Observational
Estimated 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 : November 2010
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins

Group/Cohort
Linezolid+vitamin B6
Linezolid




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Use of linezolid
Criteria

Inclusion Criteria:

  • Use of linezolid is not less than 3 days

Exclusion Criteria:

  • Serious adverse reactions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295801


Contacts
Contact: Su Longxiang, Doctor +86 13621086327

Locations
China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Director: Xie Lixin, Doctor Pneumology Department of chinese PLA General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lixin Xie, Pneumology Department of Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01295801     History of Changes
Other Study ID Numbers: 301PLAGH-20101027001
First Posted: February 15, 2011    Key Record Dates
Last Update Posted: February 15, 2011
Last Verified: October 2010

Keywords provided by Chinese PLA General Hospital:
Linezolid
Vitamin B6
Linezolid-associated cytopenias

Additional relevant MeSH terms:
Anemia
Leukopenia
Thrombocytopenia
Hematologic Diseases
Leukocyte Disorders
Blood Platelet Disorders
Vitamins
Vitamin B 6
Pyridoxal
Pyridoxine
Vitamin B Complex
Linezolid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action