Back to resultsTime To Efficacy and Onset Of Action Of Linezolid
Primary Purpose
Gram-Positive Bacterial Infections, Skin and Connective Tissue Diseases
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
linezolid
Sponsored by
About this trial
This is an interventional treatment trial for Gram-Positive Bacterial Infections
Eligibility Criteria
Inclusion Criteria: suspected grampositive infection fever > 38 C Exclusion Criteria: Infections to be treated successfully by surgical procedures
Sites / Locations
Outcomes
Primary Outcome Measures
Time to defervescence
Secondary Outcome Measures
Reduction of CRP levels Reduction of leucocyte count
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00147511
Brief Title
Time To Efficacy and Onset Of Action Of Linezolid
Official Title
Time To Efficacy and Onset Of Action Of Linezolid In Skin and Soft Tissue Infections
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
To assess the onset of action of linezolid
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram-Positive Bacterial Infections, Skin and Connective Tissue Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
linezolid
Primary Outcome Measure Information:
Title
Time to defervescence
Secondary Outcome Measure Information:
Title
Reduction of CRP levels Reduction of leucocyte count
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
suspected grampositive infection
fever > 38 C
Exclusion Criteria:
Infections to be treated successfully by surgical procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Time To Efficacy and Onset Of Action Of Linezolid
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