Post Marketing Surveillance Study on Linezolid

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NCT01564758

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gram-Positive Bacterial Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Known hypersensitivity


- Subjects diagnosed with pure gram-negative infection

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Advanced Information
Descriptive Information
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
  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
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
 (submitted: March 26, 2012)		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:

  • 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
Sex/Gender
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2012