Vitamin B6 on Relieving Linezolid-associated Cytopenias

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Chinese PLA General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01295801
First received: February 14, 2011
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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
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)
Groups/Cohorts
Linezolid+vitamin B6
Linezolid

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.

  Eligibility

Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Lixin Xie, Pneumology Department of Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01295801     History of Changes
Other Study ID Numbers: 301PLAGH-20101027001
Study First Received: February 14, 2011
Last Updated: February 14, 2011
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 29, 2014