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Trial record 1 of 1 for:    NCT01311349
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Study Evaluating Local Susceptibility Patterns Associated With Tigecycline in Comparison to Other Antibiotics

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ClinicalTrials.gov Identifier: NCT01311349
Recruitment Status : Completed
First Posted : March 9, 2011
Last Update Posted : March 9, 2011
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date August 10, 2009
First Posted Date March 9, 2011
Last Update Posted Date March 9, 2011
Study Start Date December 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study Evaluating Local Susceptibility Patterns Associated With Tigecycline in Comparison to Other Antibiotics
Official Title Evaluation of the Antimicrobial Activity In Vitro of Tigecycline in Comparison to Other Broad Spectrum Antibiotics in Isolates Collected From Patients
Brief Summary Various bacterial organisms will be tested in order to compile information regarding the effectiveness of tigecycline against certain bacteria seen in local communities.
Detailed Description This is a prospective, microbiologic in vitro evaluation which will study the susceptibility of tigecycline in disk diffusion on clinical bacterial isolates collected from inpatients and outpatients. Fourteen hospital centers participated in the program. In vitro efficacy of tigecycline will be determined through the in vitro disk diffusion activity, using FDA breakpoints.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Hospitalized patients and outpatients
Condition Infection
Intervention Not Provided
Study Groups/Cohorts 1
A listing of all isolates meeting the inclusion criteria will be maintained.
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¬†7,¬†2011)
1575
Original Actual Enrollment Same as current
Actual Study Completion Date September 2006
Primary Completion Date Not Provided
Eligibility Criteria Inclusion Criteria: Any protocol-specified microorganism isolated from the samples collected from hospitalized patients and outpatients
Sex/Gender
Sexes Eligible for Study: All
Ages Child, 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 NCT01311349
Other Study ID Numbers 3074A1-102056
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2009