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Post Marketing Surveillance Study on Linezolid

NCT ID: NCT01564758

Last Updated: 2012-08-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-03-31

Brief Summary

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The purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections.

Detailed Description

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The subjects were identified after the physician decided to prescribed the drug to the subject.

Conditions

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Gram-Positive Bacterial Infections

Keywords

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non-interventional non-comparative open-label study safety Linezolid gram positive infections Filipino

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Subjects that are diagnosed with gram positive infection

Linezolid

Intervention Type DRUG

1. Vancomycin-resistant, E. faecium, including concurrent bacteremia: Linezolid for 600mg (IV or oral) every 12 hours for 14-28 days
2. Nosocomial infection, cSSTI: Linezolid for 600mg (IV or oral) every 12 hours for 10-14 days
3. Uncomplicated SSTI: Linezolid for 400mg oral every 12 hours for 10-14 days

Interventions

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Linezolid

1. Vancomycin-resistant, E. faecium, including concurrent bacteremia: Linezolid for 600mg (IV or oral) every 12 hours for 14-28 days
2. Nosocomial infection, cSSTI: Linezolid for 600mg (IV or oral) every 12 hours for 10-14 days
3. Uncomplicated SSTI: Linezolid for 400mg oral every 12 hours for 10-14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Known hypersensitivity
* Subjects diagnosed with pure gram-negative infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5951090&StudyName=Post%20Marketing%20Surveillance%20study%20on%20Linezolid%20

To obtain contact information for a study center near you, click here.

Other Identifiers

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GRAM POSITIVE INFECTIONS

Identifier Type: -

Identifier Source: secondary_id

A5951090

Identifier Type: -

Identifier Source: org_study_id