Optic Nerve DiseasesPhase 3NCT00359632
Study to Evaluate Eye Function in Patients Taking Linezolid for Six Weeks or Greater
A Phase 3 study testing Zyvox - linezolid in people with Optic Nerve Diseases, run by Pfizer at 12 sites in 3 countries.
Trial summary
To understand and characterize the effects of linezolid on the optic nerve by observing and following patients who have been treated with linezolid for six weeks or longer for the development of signs or symptoms of visual disturbance or eye disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Optic Nerve Diseases
- What is being tested?
- Zyvox - linezolid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Nov 2008to Dec 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects who are 18 years of age or older.
- Subjects in Treated Group:
- Subjects must have received linezolid 600 mg BID for six weeks or greater and be currently on drug (or have received linezolid within 7 days of baseline evaluation).
- Subjects who have current signs or symptoms compatible with linezolid toxicity (i.e. optic or peripheral neuropathy) may be enrolled in the study if they are on linezolid at time of baseline evaluation (or have received linezolid within 7 days of baseline evaluation).
- Linezolid may be discontinued at any time at the primary physician's discretion and remain on the study.
- Women of childbearing potential must use adequate contraception
- Subjects in Control Group:
- Subjects will have a diagnosis similar to patients in the treated group and similar important co-morbidities and epidemiologic factors if possible.
Who cannot join
- Subject in Treated Group:
- Subjects with a known presence of optic or peripheral nerve damage due to another illness, condition or medication.
- Subjects with a pre-existing or a diagnosis at time of screening visit of an ophthalmologic condition that would adversely affect the study testing protocol (e.g. dense cataracts, macular degeneration, retinitis pigmentosa).
- Subjects who are currently receiving or anticipated to receive another medication, antibiotic or other, that has known potential to produce ocular or neurologic toxicity indistinguishable from that caused by linezolid or lactic acidosis.
- Subjects with a history of significant exposure, in the opinion of the investigator and with prior discussion with the medical monitor, to medications known to produce optic or peripheral neuropathy.
- Subjects with an active communicable disease (i.e., tuberculosis assessed as currently communicable) and subjects on active treatment for tuberculosis or other mycobacterial disease that include drugs that have known potential to produce ocular or neurologic toxicity.
Show all 14Show fewer
- Subjects with severe liver disease or abnormal liver function test.
- Subjects in Control Group:
- Subjects must not currently be taking linezolid or have received it for more than 7 days at any time.
- Subjects with a known presence of optic or peripheral nerve damage due to another illness, condition or medication.
- Subjects with a pre-existing or a diagnosis at the screening visit of an ophthalmologic condition that would adversely affect the study testing protocol (e.g. dense cataracts, macular degeneration, retinitis pigmentosa).
- Subjects who are currently receiving another medication, antibiotic or other, that has known potential to produce ocular or neurologic toxicity indistinguishable from that caused by linezolid or lactic acidosis.
- Subjects with a history of significant exposure, in the opinion of the investigator and with prior discussion with the medical monitor, to medications known to produce optic or peripheral neuropathy.
- Subjects with an active communicable disease (i.e., tuberculosis assessed as currently communicable) and subjects on active treatment for tuberculosis or other mycobacterial disease that include drugs that have known potential to produce ocular or neurologic toxicity.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States7 sites
Henry Ford Health System
Detroit, Michigan, 48202
St. Bernards Research Center
Jonesboro, Arkansas, 72401
University of Minnesota, Department of Medicine/Division of Infectious Diseases
Minneapolis, Minnesota, 55455
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Drexel University College of Medicine, Partnership Comprehensive Care Practice
Philadelphia, Pennsylvania, 19102
Associates in Infectious Disease and Tropical Medicine
Pittsburgh, Pennsylvania, 15206
Triple O Research Institute, PA
West Palm Beach, Florida, 33401
Italy4 sites
Azienda Ospedaliera Universitaria di San Martino
Genova, 16132
Ospedale San Martino, Clinica Malattie Infettive
Genova, 16132
Università di Genova
Genova, 16132
Clinica Malattie Infettive, Azienda Ospedaliero Universitaria Santa Maria della Misericordia
Udine, 33100
Sweden1 site
Infektionskliniken 1-73, Karolinska Universitetssjukhuset Huddinge
Stockholm, 141 86
About this study
Official title: Prospective Study Of Ophthalmologic Function In Patients Receiving Linezolid For Six Weeks Or Greater
To understand and characterize the effects of linezolid on the optic nerve by observing and following patients who have been treated with linezolid for six weeks or longer for the development of signs or symptoms of visual disturbance or eye disorders.
Read the detailed description
Characterize Optic Side Effect
- Conditions
- Optic Nerve Diseases
- Being tested
- Zyvox - linezolid, Matched control
- Keywords
- Optic neuropathy following long-term linezolid use
- Medical subject headings
- Optic Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zyvox - linezolidDrug
Observation and testing in patients for whom their treating physician has determined linezolid is an appropriate therapy. Eye tests performed for subjects who have received linezolid for at least 6 weeks and matching controls who have received other antibiotics for similar types of infections.
Matched controlDrug
Matched controls received an antibiotic other than linezolid for at least 6 weeks prior to baseline visit. The control group had only a baseline visit and there were no post baseline study visits.
| Study group | Role | What they receive |
|---|---|---|
| Linezolid | Experimental | Subjects have received at least 6 weeks of linezolid therapy (600 mg BID). Continued duration of linezolid treatment is based on treating physician's benefit/risk assessment. A matching control who did not receive linezolid will be selected for each linezolid treated subject. Receives: Drug: Zyvox - linezolid |
| Matched control | Active comparator | Control subjects individually matched to linezolid subjects (on age, gender and type of infection) who received at least 6 weeks of antibiotics other than linezolid. Control group assessed only at baseline visit to assess presence of background abnormalities in the study test panel. Receives: Drug: Matched control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With an Adverse Event
Measured: Through and including 28 calendar days after the last administration of the investigational product
Secondary outcomes (1)
Percentage of Participants by Clinical Outcome of Infection at End of Study
Clinical response was evaluated at the End of Study visit (30 days after last dose) as Cure, Improvement, Failure, Unknown or Other. Clinical response was based primarily on the global assessment of the clinical presentation of the subject made by the investigator at that evaluation timepoint. The clinical response classifications were defined as follows. Cure: Resolution of the clinical signs and symptoms of infection, when compared to Baseline. No additional antimicrobial treatment is required for the disease under study. Improvement: Improvement in 2 or more, but not all, of the clinical signs and symptoms of infection, when compared with Baseline. No additional antimicrobial treatment is required for the disease under study. Failure: Persistence or progression of Baseline clinical signs and symptoms of infection, or development of new clinical findings consistent with active infection. Unknown: Inability to assess clinical response.
Measured: At End of Study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2006 (estimated)
- Study startNov 2008
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Study was stopped due to poor enrollment on 28 Feb 2012. Reason for termination was not due to safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Optic Nerve DiseasesStudies 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 3
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT00359632
- Sponsor's protocol ID
- A5951110
- Other IDs
- 2006-002303-14
- Status last verified
- Jun 2015
- First submitted
- 28 Jul 2006
- Last updated
- 26 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Of Ophthalmologic Function In Patients Receiving Linezolid For Six Weeks Or Greater
- ClinicalTrials.gov ID
- NCT00359632
- Acronym / sponsor ID
- A5951110
- Conditions
- Optic Nerve Diseases
- Keywords
- Optic neuropathy following long-term linezolid use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to poor enrollment on 28 Feb 2012. Reason for termination was not due to safety concerns.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Aug 2006 (estimated)
- Results
- Posted 26 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To understand and characterize the effects of linezolid on the optic nerve by observing and following patients who have been treated with linezolid for six weeks or longer for the development of signs or symptoms of visual disturbance or eye disorders.
Detailed description
Characterize Optic Side Effect
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linezolid | Experimental | Drug: Zyvox - linezolidSubjects have received at least 6 weeks of linezolid therapy (600 mg BID). Continued duration of linezolid treatment is based on treating physician's benefit/risk assessment. A matching control who did not receive linezolid will be selected for each linezolid treated subject. |
| Matched control | Active comparator | Drug: Matched controlControl subjects individually matched to linezolid subjects (on age, gender and type of infection) who received at least 6 weeks of antibiotics other than linezolid. Control group assessed only at baseline visit to assess presence of background abnormalities in the study test panel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female subjects who are 18 years of age or older.
- Subjects in Treated Group:
- Subjects must have received linezolid 600 mg BID for six weeks or greater and be currently on drug (or have received linezolid within 7 days of baseline evaluation).
- Subjects who have current signs or symptoms compatible with linezolid toxicity (i.e. optic or peripheral neuropathy) may be enrolled in the study if they are on linezolid at time of baseline evaluation (or have received linezolid within 7 days of baseline evaluation).
- Linezolid may be discontinued at any time at the primary physician's discretion and remain on the study.
Key exclusion criteria (14 listed)
- Subject in Treated Group:
- Subjects with a known presence of optic or peripheral nerve damage due to another illness, condition or medication.
- Subjects with a pre-existing or a diagnosis at time of screening visit of an ophthalmologic condition that would adversely affect the study testing protocol (e.g. dense cataracts, macular degeneration, retinitis pigmentosa).
- Subjects who are currently receiving or anticipated to receive another medication, antibiotic or other, that has known potential to produce ocular or neurologic toxicity indistinguishable from that caused by linezolid or lactic acidosis.
- Subjects with a history of significant exposure, in the opinion of the investigator and with prior discussion with the medical monitor, to medications known to produce optic or peripheral neuropathy.
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 |
|---|---|---|
| Zyvox - linezolidObservation and testing in patients for whom their treating physician has determined linezolid is an appropriate therapy. Eye tests performed for subjects who have received linezolid for at least 6 weeks and matching controls who have received other antibiotics for similar types of infections. | Drug | Linezolid |
| Matched controlMatched controls received an antibiotic other than linezolid for at least 6 weeks prior to baseline visit. The control group had only a baseline visit and there were no post baseline study visits. | Drug | Matched control |
Primary outcome
Percentage of Participants With an Adverse Event
Time frame: Through and including 28 calendar days after the last administration of the investigational product
1 secondary outcome
Percentage of Participants by Clinical Outcome of Infection at End of Study
Time frame: At End of Study visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zyvox - linezolid in people with Optic Nerve Diseases, run by Pfizer at 12 sites in 3 countries.
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 8 inclusion and 14 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: stopped early, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Italy, Sweden. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With an Adverse Event (time frame: Through and including 28 calendar days after the last administration of the investigational product). 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 26 Jun 2015.