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NCT00147511 Clinical Trial

Time To Efficacy and Onset Of Action Of Linezolid

Gram-Positive Bacterial Infections Clinical Trial

Official title:
Time To Efficacy and Onset Of Action Of Linezolid In Skin and Soft Tissue Infections

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00147511
Other study ID # OXAA-0026-162
Secondary ID
Status Completed
Phase Phase 4
First received September 2, 2005
Last updated May 9, 2011
Start date June 2003
Est. completion date June 2005

Study information
Verified date May 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

To assess the onset of action of linezolid

Recruitment information / eligibility
Status Completed
Enrollment 118
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- suspected grampositive infection

- fever > 38 C

Exclusion Criteria:

- Infections to be treated successfully by surgical procedures

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• linezolid

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Time to defervescence
Secondary Reduction of CRP levels Reduction of leucocyte count
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