- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00488397
Tigecycline In-Vitro Surveillance Study In Taiwan
March 21, 2011 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
In-vitro surveillance study of tigecycline (Tygacil) in Taiwan.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
7902
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Taiwan
-
Taipei, Taiwan, China, 100
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
hospital or community acquired infection
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
in vitro study therefore not applicable
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
in vitro study therefore not applicable
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
June 18, 2007
First Submitted That Met QC Criteria
June 18, 2007
First Posted (Estimate)
June 20, 2007
Study Record Updates
Last Update Posted (Estimate)
March 22, 2011
Last Update Submitted That Met QC Criteria
March 21, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3074A1-102091
- B1811055 (Other Identifier: Pfizer)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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