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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002303-14 | EudraCT Number |
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Study was stopped due to poor enrollment on 28 Feb 2012. Reason for termination was not due to safety concerns.
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zyvox - linezolid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Adverse Event | Through and including 28 calendar days after the last administration of the investigational product |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Bernards Research Center | Jonesboro | Arkansas | 72401 | United States | ||
| Triple O Research Institute, PA |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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There were separate selection criteria for subjects in the treated and control groups. At the Screening/Baseline visit (Day 1), subjects were eligible for the study after verification that they met the relevant inclusion/exclusion criteria and the study had been explained to them.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Linezolid | Participants received linezolid either as tablets, by mouth (PO) or as an intravenous (IV) infusion at a dose of 600 milligrams (mg), twice daily (BID). Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Matched control | Drug | 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. |
|
| At End of Study visit |
| West Palm Beach |
| Florida |
| 33401 |
| United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| University of Minnesota, Department of Medicine/Division of Infectious Diseases | Minneapolis | Minnesota | 55455 | United States |
| Drexel University College of Medicine, Partnership Comprehensive Care Practice | Philadelphia | Pennsylvania | 19102 | United States |
| Associates in Infectious Disease and Tropical Medicine | Pittsburgh | Pennsylvania | 15206 | United States |
| Azienda Ospedaliera Universitaria di San Martino | Genova | 16132 | Italy |
| Ospedale San Martino, Clinica Malattie Infettive | Genova | 16132 | Italy |
| Università di Genova | Genova | 16132 | Italy |
| Clinica Malattie Infettive, Azienda Ospedaliero Universitaria Santa Maria della Misericordia | Udine | 33100 | Italy |
| Infektionskliniken 1-73, Karolinska Universitetssjukhuset Huddinge | Stockholm | 141 86 | Sweden |
| FG001 | Control | Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Linezolid | Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days). |
| BG001 | Control | Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With an Adverse Event | Posted | Number | Percentage of Participants | Through and including 28 calendar days after the last administration of the investigational product |
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| Secondary | 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. | Posted | Number | Percentage of Participants | At End of Study visit |
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Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Linezolid | Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days). | 6 | 24 | 20 | 24 | ||
| EG001 | Control | Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel. | 0 | 9 | 1 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythropoiesis abnormal | Blood and lymphatic system disorders | MedDRA v16.1 |
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| Sideroblastic anaemia | Blood and lymphatic system disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Condition aggravated | General disorders | MedDRA v16.1 | Non-systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA v16.1 |
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| Pyrexia | General disorders | MedDRA v16.1 |
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| Sepsis | Infections and infestations | MedDRA v16.1 |
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| Polyneuropathy | Nervous system disorders | MedDRA v16.1 |
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| Hypertension | Vascular disorders | MedDRA v16.1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v16.1 |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA v16.1 |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA v16.1 |
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| Diabetic retinal oedema | Eye disorders | MedDRA v16.1 |
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| Narrow anterior chamber angle | Eye disorders | MedDRA v16.1 |
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| Optic neuropathy | Eye disorders | MedDRA v16.1 |
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| Retinal disorder | Eye disorders | MedDRA v16.1 |
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| Toxic optic neuropathy | Eye disorders | MedDRA v16.1 |
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| Visual impairment | Eye disorders | MedDRA v16.1 |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA v16.1 |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v16.1 |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v16.1 |
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| Nausea | Gastrointestinal disorders | MedDRA v16.1 |
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| Tooth discolouration | Gastrointestinal disorders | MedDRA v16.1 |
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| Vomiting | Gastrointestinal disorders | MedDRA v16.1 |
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| Asthenia | General disorders | MedDRA v16.1 |
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| Chest pain | General disorders | MedDRA v16.1 |
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| Fatigue | General disorders | MedDRA v16.1 |
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| Malaise | General disorders | MedDRA v16.1 |
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| Oedema peripheral | General disorders | MedDRA v16.1 |
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| Folliculitis | Infections and infestations | MedDRA v16.1 |
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| Oral candidiasis | Infections and infestations | MedDRA v16.1 |
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| Vulvovaginal mycotic infection | Infections and infestations | MedDRA v16.1 |
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| Complications of transplant surgery | Injury, poisoning and procedural complications | MedDRA v16.1 |
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| Blood lactic acid increased | Investigations | MedDRA v16.1 |
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| Haemoglobin decreased | Investigations | MedDRA v16.1 |
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| Hepatic enzyme increased | Metabolism and nutrition disorders | MedDRA v16.1 |
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| Platelet count increased | Investigations | MedDRA v16.1 |
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| Protein total increased | Investigations | MedDRA v16.1 |
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| Vitamin B1 decreased | Investigations | MedDRA v16.1 |
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| Vitamin B12 decreased | Investigations | MedDRA v16.1 |
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| Weight decreased | Investigations | MedDRA v16.1 |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA v16.1 |
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| Folate deficiency | Metabolism and nutrition disorders | MedDRA v16.1 |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v16.1 |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA v16.1 |
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| Vitamin B1 deficiency | Metabolism and nutrition disorders | MedDRA v16.1 |
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| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA v16.1 |
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| Vitamin B6 deficiency | Metabolism and nutrition disorders | MedDRA v16.1 |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v16.1 |
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| Dysgeusia | Nervous system disorders | MedDRA v16.1 |
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| Headache | Nervous system disorders | MedDRA v16.1 |
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| Neuropathy peripheral | Nervous system disorders | MedDRA v16.1 |
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| Paraesthesia | Nervous system disorders | MedDRA v16.1 |
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| Polyneuropathy | Nervous system disorders | MedDRA v16.1 |
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| Sinus headache | Nervous system disorders | MedDRA v16.1 |
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| Somnolence | Nervous system disorders | MedDRA v16.1 |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 |
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This pilot study was exploratory and not designed to be powered for safety or efficacy. Controls were not followed post-baseline whereas linezolid patients returned for multiple study visits. The study was terminated early due to slow enrollment.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| ID | Term |
|---|---|
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D016022 | Case-Control Studies |
| ID | Term |
|---|---|
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Male |
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| Severe adverse events, % |
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| Discontinued due to adverse events, % |
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| Dose Reduced or Temporary Discontinuation, % |
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| Participants |
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