A Phase 3 interventional study of Zyvox - linezolid and Matched control in Optic Nerve Diseases, sponsored by Pfizer. Terminated at 12 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-26.
Sponsored by Pfizer · Phase 3 and Interventional
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.
Characterize Optic Side Effect
974 studies on the registry are indexed under Nervous System Diseases; 252 are open to participants now.
This study's enrollment of 34 is below the median of 48 across 623 interventional studies indexed under Nervous System Diseases.
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Exclusion Criteria:
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.
Drug: Zyvox - linezolid
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.
Drug: Matched control
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 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.
Percentage of Participants With an Adverse Event
Time frame: Through and including 28 calendar days after the last administration of the investigational product
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.
Time frame: At End of Study visit
Nine centers (2 centers in Italy, 1 center in Sweden, and 6 centers in the US) enrolled subjects for inclusion in the study. Sites were selected based on their capability to perform the comprehensive testing and to treat types of infections that might require therapy with linezolid for 6 weeks or longer.
| Milestone | Linezolid | Control |
|---|---|---|
| Started | 24 | 9 |
| Completed | 20 | 9 |
| Not completed | 4 | 0 |
| Withdrew: Death | 2 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Non-compliance with visit schedule | 1 | 0 |
| Percentage of Participants | Linezolid | Control |
|---|---|---|
| Adverse events, % | 83.3 | 11.1 |
| Serious adverse events, % | 25.0 | 0 |
| Severe adverse events, % | 12.5 | 0 |
| Discontinued due to adverse events, % | 29.2 | 0 |
| Dose Reduced or Temporary Discontinuation, % | 12.5 | 0 |
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.
| Percentage of Participants | Linezolid |
|---|---|
| Cure, % | 47.6 |
| Improvement, % | 42.9 |
| Failure, % | 0 |
| Unknown, % | 0 |
| Other, % | 9.5 |
Collected over Through and including 28 calendar days after the last administration of the investigational product. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Linezolid | — | 6/24 (25%) | 20/24 (83.3%) |
| Control | — | 0/9 (0%) | 1/9 (11.1%) |
| Event | Linezolid | Control |
|---|---|---|
| PolyneuropathyNervous system disorders | 2/24 | 0/9 |
| Erythropoiesis abnormalBlood and lymphatic system disorders | 1/24 | 0/9 |
| Sideroblastic anaemiaBlood and lymphatic system disorders | 1/24 | 0/9 |
| Condition aggravatedGeneral disorders | 1/24 | 0/9 |
| General physical health deteriorationGeneral disorders | 1/24 | 0/9 |
| PyrexiaGeneral disorders | 1/24 | 0/9 |
| SepsisInfections and infestations | 1/24 | 0/9 |
| HypertensionVascular disorders | 1/24 | 0/9 |
| Event | Linezolid | Control |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 6/24 | 0/9 |
| NauseaGastrointestinal disorders | 3/24 | 0/9 |
| VomitingGastrointestinal disorders | 3/24 | 0/9 |
| Folate deficiencyMetabolism and nutrition disorders | 3/24 | 0/9 |
| Neuropathy peripheralNervous system disorders | 3/24 | 0/9 |
| Narrow anterior chamber angleEye disorders | 0/24 | 1/9 |
| Gastrointestinal disorderGastrointestinal disorders | 2/24 | 0/9 |
| AstheniaGeneral disorders | 2/24 | 0/9 |
| Platelet count increasedInvestigations | 2/24 | 0/9 |
| Vitamin B1 deficiencyMetabolism and nutrition disorders | 2/24 | 0/9 |
| Age, Continuous(Years) | Linezolid | Control | Total |
|---|---|---|---|
| Mean | 53.4 ± 13.38 | 50.1 ± 11.86 | 52.5 ± 12.89 |
| Sex: Female, Male(Participants) | Linezolid | Control | Total |
|---|---|---|---|
| Female | 10 | 6 | 16 |
| Male | 14 | 3 | 17 |
This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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