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Post Marketing Surveillance Study on Linezolid

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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

NCT01564758
Pfizer
Completed
Post Marketing Surveillance Study on Linezolid

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Descriptive Information
Brief TitlePost Marketing Surveillance Study on Linezolid
Official TitlePost Marketing Surveillance on the Efficacy, Safety and Tolerability of Linezolid (Zyvox) in the Treatment of Gram Positive Infections
Brief SummaryThe purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections.
Detailed DescriptionThe subjects were identified after the physician decided to prescribed the drug to the subject.
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationAdult, Filipino patients diagnosed with gram positive infection
ConditionGram-Positive Bacterial Infections
InterventionDrug: 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/CohortsGroup 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 StatusCompleted
Actual Enrollment
 (submitted: March 26, 2012)
99
Original Actual EnrollmentSame as current
Actual Study Completion DateMarch 2005
Actual Primary Completion DateMarch 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01564758
Other Study ID NumbersA5951090
GRAM POSITIVE INFECTIONS
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2012

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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