Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment
NCT01072539
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
Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :
Adults 18 years of age or older, who have one of the followings:
- Complicated skin and skin structure infections
- Complicated intra-abdominal infections
- Community-acquired bacterial pneumonia
Subjects presenting with any of the following will not be included in the study:
- Patients who have known hypersensitivity to tigecycline
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency, or glucose-galactose malabsorption
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title | Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment | |||
Official Title | A Post-marketing Surveillance (Pms) Study Of Safety And Effectiveness In Patients With Tigecycline Treatment | |||
Brief Summary | The primary objective of this study is to identify any changes on the safety profile of adverse events and serious adverse events. And the secondary objective is to evaluate clinical response in the clinically evaluable population at test-of cure (TOC) or at the end of treatment (EOT) assessment, and microbiologic response at the subject level, if available. | |||
Detailed Description | Prior to the conduct of this study, the investigator will explain the study objective, etc to prospective subjects on the basis of "explanatory material." The informed consent will be obtained in written form by each subject voluntarily. | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | General Hospitals | |||
Condition |
| |||
Intervention | Drug: tigecycline
As prescribed by physician in usual clinical practice Other Name: Tygacil | |||
Study Groups/Cohorts | Patients who have approved indications of Tygacil
Approved indications of Tygacil -complicated intraabdominal infection, complicated skin and skin structure infection, community-acquired bacterial pneumonia Intervention: Drug: tigecycline | |||
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 | 3172 | |||
Original Estimated Enrollment | 3000 | |||
Actual Study Completion Date | April 2015 | |||
Actual Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria: Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study : Adults 18 years of age or older, who have one of the followings:
Exclusion Criteria: Subjects presenting with any of the following will not be included in the study:
| |||
Sex/Gender | Not Provided | |||
Ages | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01072539 | |||
Other Study ID Numbers | 3074X1-4527 B1811040 ( Other Identifier: Alias Study Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | April 2016 |