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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01295801
Other study ID # 301PLAGH-20101027001
Secondary ID
Status Recruiting
Phase N/A
First received February 14, 2011
Last updated February 14, 2011
Start date November 2010
Est. completion date September 2011

Study information

Verified date October 2010
Source Chinese PLA General Hospital
Contact Su Longxiang, Doctor
Phone +86 13621086327
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date September 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Use of linezolid is not less than 3 days

Exclusion Criteria:

- Serious adverse reactions

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
China Chinese PLA General Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

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