CytopeniasNCT01295801
Vitamin B6 on Relieving Linezolid-associated Cytopenias
An observational study of Cytopenias and Erythropenia (Diagnosis), run by Chinese PLA General Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cytopenias, Erythropenia (Diagnosis)
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Nov 2010to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Use of linezolid
Who may be able to join
- Use of linezolid is not less than 3 days
Who cannot join
- Serious adverse reactions
Trial locations and contacts
1 site in 1 country.
Su Longxiang, Doctor contact
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
About this study
Official title: The Effects and Mechanism of Vitamin B6 on Relieving Linezolid-associated Cytopenias
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.
Read the 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.
- Conditions
- Cytopenias, Erythropenia (Diagnosis)
- Keywords
- Linezolid, Vitamin B6, Linezolid-associated cytopenias
- Medical subject headings
- Cytopenia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Linezolid+vitamin B6 | Not described | |
| Linezolid | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionJul 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CytopeniasStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Xie Lixin, Doctor, Study director, Pneumology Department of chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295801
- Sponsor's protocol ID
- 301PLAGH-20101027001
- Status last verified
- Oct 2010
- First submitted
- 14 Feb 2011
- Last updated
- 15 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Deng J, Su LX, Liang ZX, Liang LL, Yan P, Jia YH, Zhang XG, Feng D, Xie LX. Effects of vitamin b6 therapy for sepsis patients with linezolid-associated cytopenias: a retrospective study. Curr Ther Res Clin Exp. 2013 Jun;74:26-32. doi: 10.1016/j.curtheres.2012.12.002.
PubMed 24385027
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects and Mechanism of Vitamin B6 on Relieving Linezolid-associated Cytopenias
- ClinicalTrials.gov ID
- NCT01295801
- Acronym / sponsor ID
- 301PLAGH-20101027001
- Conditions
- Cytopenias, Erythropenia (Diagnosis)
- Keywords
- Linezolid, Vitamin B6, Linezolid-associated cytopenias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 15 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linezolid+vitamin B6 | – | – |
| Linezolid | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Use of linezolid
Key inclusion criteria (1 listed)
- Use of linezolid is not less than 3 days
Key exclusion criteria (1 listed)
- Serious adverse reactions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2011.
- Derived from this study: PubMed 24385027Deng J, Su LX, Liang ZX, Liang LL, Yan P, Jia YH, Zhang XG, Feng D, Xie LX. Effects of vitamin b6 therapy for sepsis patients with linezolid-associated cytopenias: a retrospective study. Curr Ther Res Clin Exp. 2013 Jun;74:26-32. doi: 10.1016/j.curtheres.2012.12.002.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Su Longxiang, Doctor contact
Xie Lixin, Doctor study director
Pneumology Department of chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytopenias and Erythropenia (Diagnosis), run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Su Longxiang, Doctor (+86 13621086327), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01295801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2011.