Gram Positive InfectionPhase 1NCT01544673
Effect of Linezolid on Ex Vivo Neutrophil and Monocyte Function in Healthy Males
A Phase 1 study testing linezolid in people with Gram Positive Infection, run by Pfizer at 1 site in United States.
Trial summary
Results from previous studies have been inconclusive and the effect of linezolid on cytokines remains unclear. This study is designed to evaluate the effect of linezolid on the functionality of white blood cells (neutrophils and monocytes) in healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gram Positive Infection
- What is being tested?
- linezolid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Apr 2012
- Phase
- Phase 1
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between the ages of 20 and 45 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Who cannot join
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- Subject who had a bacterial/viral infection within 2 weeks prior to the first dose of study medication.
- Subjects with current or prior neutropenia (eg, <1.4 x 109 neutrophils /L).
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: An Open-label, Placebo-controlled Phase 1 Study to Evaluate the Effect of Linezolid on Ex Vivo Neutrophil and Monocyte Function in Healthy Male Subjects
Results from previous studies have been inconclusive and the effect of linezolid on cytokines remains unclear. This study is designed to evaluate the effect of linezolid on the functionality of white blood cells (neutrophils and monocytes) in healthy subjects.
- Conditions
- Gram Positive Infection
- Being tested
- linezolid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linezolidDrug
Also called Zyvox
600 mg oral tablet twice daily for 4.5 days
PlaceboDrug
500 mg oral placebo twice daily for 4.5 days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Not described Receives: Drug: linezolid |
| Arm B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in phagocytosis of gram-negative bacteria by neutrophils
Measured: Baseline, day 4 and day 5
Change from baseline in phagocytosis of gram-negative bacteria by monocytes
Measured: Baseline, day 4 and day 5
Change from baseline in interleukin-1 receptor antagonist secretion in response to lipopolysaccharide stimulation
Measured: Baseline, day 4 and day 5
Change from baseline in interleukin-1-beta secretion in response to lipopolysaccharide stimulation
Measured: Baseline, day 4 and day 5
Change from baseline in interleukin-6 secretion in response to lipopolysaccharide stimulation
Measured: Baseline, day 4 and day 5
Change from baseline in interleukin-8 secretion in response to lipopolysaccharide stimulation
Measured: Baseline, day 4 and day 5
Change from baseline in tumor necrosis factor alpha secretion in response to lipopolysaccharide stimulation
Measured: Baseline, day 4 and day 5
Secondary outcomes (3)
Linezolid peak concentration on day 4
Measured: day 4
Linezolid peak concentration on day 5
Measured: day 5
Linezolid trough concentration on day 5
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram Positive InfectionStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544673
- Sponsor's protocol ID
- A5951164
- Status last verified
- Apr 2012
- First submitted
- 29 Feb 2012
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Placebo-controlled Phase 1 Study to Evaluate the Effect of Linezolid on Ex Vivo Neutrophil and Monocyte Function in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01544673
- Acronym / sponsor ID
- A5951164
- Conditions
- Gram Positive Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 6 Mar 2012 (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.
Results from previous studies have been inconclusive and the effect of linezolid on cytokines remains unclear. This study is designed to evaluate the effect of linezolid on the functionality of white blood cells (neutrophils and monocytes) in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: linezolid |
| Arm B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects between the ages of 20 and 45 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Key exclusion criteria (3 listed)
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- Subject who had a bacterial/viral infection within 2 weeks prior to the first dose of study medication.
- Subjects with current or prior neutropenia (eg, <1.4 x 109 neutrophils /L).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| linezolidAlso: Zyvox600 mg oral tablet twice daily for 4.5 days | Drug | Arm A |
| Placebo500 mg oral placebo twice daily for 4.5 days | Drug | Arm B |
Primary outcome
Change from baseline in phagocytosis of gram-negative bacteria by neutrophils
Time frame: Baseline, day 4 and day 5
Change from baseline in phagocytosis of gram-negative bacteria by monocytes
Time frame: Baseline, day 4 and day 5
Change from baseline in interleukin-1 receptor antagonist secretion in response to lipopolysaccharide stimulation
Time frame: Baseline, day 4 and day 5
Change from baseline in interleukin-1-beta secretion in response to lipopolysaccharide stimulation
Time frame: Baseline, day 4 and day 5
Change from baseline in interleukin-6 secretion in response to lipopolysaccharide stimulation
Time frame: Baseline, day 4 and day 5
Change from baseline in interleukin-8 secretion in response to lipopolysaccharide stimulation
Time frame: Baseline, day 4 and day 5
Change from baseline in tumor necrosis factor alpha secretion in response to lipopolysaccharide stimulation
Time frame: Baseline, day 4 and day 5
3 secondary outcomes
Linezolid peak concentration on day 4
Time frame: day 4
Linezolid peak concentration on day 5
Time frame: day 5
Linezolid trough concentration on day 5
Time frame: day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Gram Positive Infection
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin-Resistant Staphylococcus Aureus Colonization
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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing linezolid in people with Gram Positive Infection, run by Pfizer at 1 site in United States.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 30 Apr 2012. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in phagocytosis of gram-negative bacteria by neutrophils (time frame: Baseline, day 4 and day 5). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2012.