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Trial record 1 of 1 for:    NCT00488397
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Tigecycline In-Vitro Surveillance Study In Taiwan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00488397
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : March 22, 2011
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date June 18, 2007
First Posted Date June 20, 2007
Last Update Posted Date March 22, 2011
Study Start Date August 2006
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 12, 2010)
  • Prior to 2009: Susceptibility data of minimum inhibitory concentration (MIC), MIC50, MIC90by pathogen, tested by E-test. [ Time Frame: in vitro study therefore not applicable ]
  • Post-2009: Susceptibility data of MIC, MIC50, MIC90 by pathogen, tested by micro-dilution method [ Time Frame: in vitro study therefore not applicable ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00488397 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 12, 2010)
  • Prior to 2009: 1. Susceptibility data of minimum inhibitory concentration (MIC), MIC50, MIC90 by pathogen, tested by micro-dilution method 2. Susceptibility data of inhibition zone diameter(mm) by pathogen, tested by paper disc. [ Time Frame: in vitro study therefore not applicable ]
  • Post-2009: Susceptibility data of inhibition zone diameter (mm) by pathogen, tested by paper disc. [ Time Frame: in vitro study therefore not applicable ]
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 Tigecycline In-Vitro Surveillance Study In Taiwan
Official Title Tigecycline In-Vitro Surveillance Study In Taiwan
Brief Summary In-vitro surveillance study of tigecycline (Tygacil) in Taiwan.
Detailed Description Not Provided
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 hospital or community acquired infection
Condition Community Acquired Infections
Intervention Other: In-vitro testing
This is an in-vitro study thus only one group in the study and there is no intervention treatment nor procedure involved in this study.
Study Groups/Cohorts 1
Intervention: Other: In-vitro testing
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 11, 2011)
7902
Original Enrollment
 (submitted: June 18, 2007)
6000
Actual Study Completion Date February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinically relevant causative isolate (no duplicates) - The isolate must meet the laboratory criteria of "significant pathogen" and be considered the "probable causative agent" of a hospital or community acquired infection.
  • Sources - All body sites are acceptable clinical sources for isolates to be included in this study (Intra-abdominal infection, tracheal secretion/bronchoalveolar lavage, blood culture, wound smear). However, no more than 10 % of all isolates can come from urine cultures.
  • Within study group - Only isolates defined by the protocol are to be included.

Exclusion Criteria:

  • Limited isolates from sources - No more than 10 % of all isolates from this study will be derived from urine cultures.
  • No banked or stored isolates.
  • No duplicate isolates - Only one isolate per patient is permitted.
  • Outside study group - Any isolate other than those defined by protocol.
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 China
Removed Location Countries Taiwan
 
Administrative Information
NCT Number NCT00488397
Other Study ID Numbers 3074A1-102091
B1811055 ( Other Identifier: Pfizer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date March 2011