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- 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:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | March 2011 | |||