ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
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- Taipei, Taiwan
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 | 7902 | |||
Original Enrollment | 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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | March 2011 |