Vitamin B6 on Relieving Linezolid-associated Cytopenias

Status Recruiting

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.

Clinical Trial 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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01295801
Study type	Observational
Source	Chinese PLA General Hospital
Contact	Su Longxiang, Doctor
Phone	+86 13621086327
Status	Recruiting
Phase	N/A
Start date	November 2010
Completion date	September 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00002009` - A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia	Phase 1
Completed	`NCT00002281` - A Study of Granulocyte Colony-Stimulating Factor Plus Recombinant Erythropoietin Plus Zidovudine in Patients With AIDS or AIDS-Related Complex	N/A
Completed	`NCT00000711` - Granulocyte-Macrophage Colony-Stimulating Factor and Zidovudine: A Phase I Study of Concurrent Administration in Patients With AIDS and Severe ARC	Phase 1
Completed	`NCT00002073` - A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy	N/A
Completed	`NCT00002006` - A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility	Phase 1
Completed	`NCT00002072` - A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy	N/A
Completed	`NCT00002303` - The Safety and Effectiveness of r-HuEPO in Patients With AIDS or Advanced AIDS-Related Complex (ARC) Who Are Anemic	N/A
Completed	`NCT00002258` - A Phase I, Open Label Trial to Evaluate the Safety, Tolerance and Biological Effects of SDZ ILE-964 (Recombinant Human Interleukin-3, RhIL-3) in HIV Infected Patients With Cytopenia	Phase 1
Completed	`NCT00002071` - A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy	N/A
Completed	`NCT00002008` - An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia	Phase 1
Completed	`NCT00002302` - The Safety and Effectiveness of r-HuEPO in Patients With AIDS and Anemia Caused by AIDS and Treatment With AZT	N/A
Completed	`NCT00002263` - A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine	N/A
Completed	`NCT00002042` - A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia	N/A
Completed	`NCT00002022` - Treatment Program for Anemia in AIDS Patients	N/A
No longer available	`NCT01200017` - Expanded Access Protocol (EAP) Using the CliniMACS® Device for Pediatric Haplocompatible Donor Stem Cell Transplant
Completed	`NCT00002007` - A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia	N/A
Completed	`NCT00002126` - A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-Methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection.	Phase 2