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Vitamin B6 on Relieving Linezolid-associated Cytopenias

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Chinese PLA General Hospital.
Recruitment status was:  Recruiting
Information provided by:
Chinese PLA General Hospital Identifier:
First received: February 14, 2011
Last updated: NA
Last verified: October 2010
History: No changes posted
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.

Cytopenias Erythropenia (Diagnosis)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effects and Mechanism of Vitamin B6 on Relieving Linezolid-associated Cytopenias

Resource links provided by NLM:

Further study details as provided by Chinese PLA General Hospital:

Estimated Enrollment: 80
Study Start Date: November 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Linezolid+vitamin B6

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.

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

Inclusion Criteria:

  • Use of linezolid is not less than 3 days

Exclusion Criteria:

  • Serious adverse reactions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01295801

Contact: Su Longxiang, Doctor +86 13621086327

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lixin Xie, Pneumology Department of Chinese PLA General Hospital Identifier: NCT01295801     History of Changes
Other Study ID Numbers: 301PLAGH-20101027001
Study First Received: February 14, 2011
Last Updated: February 14, 2011

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

Additional relevant MeSH terms:
Hematologic Diseases
Leukocyte Disorders
Blood Platelet Disorders
Vitamin B 6
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017