ABOUT THIS STUDY
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- Has clinical diagnosis of of the following, including cases with concurrent bacteremia, when suspected or known to be caused by susceptible strains of anaerobic or aerobic gram positive microorganisms - nosocomial pneumonia, community acquired pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infection, and vancomycin-resistant E. faecium
- Male or female, 18 years old and above
- Known hypersensitivity
- Subjects diagnosed with pure gram-negative infection
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Descriptive Information | ||||
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Brief Title | Post Marketing Surveillance Study on Linezolid | |||
Official Title | Post Marketing Surveillance on the Efficacy, Safety and Tolerability of Linezolid (Zyvox) in the Treatment of Gram Positive Infections | |||
Brief Summary | The purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections. | |||
Detailed Description | The subjects were identified after the physician decided to prescribed the drug to the subject. | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Adult, Filipino patients diagnosed with gram positive infection | |||
Condition | Gram-Positive Bacterial Infections | |||
Intervention | Drug: Linezolid
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Study Groups/Cohorts | Group 1
Subjects that are diagnosed with gram positive infection Intervention: Drug: Linezolid | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 99 | |||
Original Actual Enrollment | Same as current | |||
Actual Study Completion Date | March 2005 | |||
Actual Primary Completion Date | March 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01564758 | |||
Other Study ID Numbers | A5951090 GRAM POSITIVE INFECTIONS | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Pfizer | |||
Verification Date | June 2012 |