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Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

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NCT01072539

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Ajou University Hospital
Suwon, Gyeonggi-do, 443-380 Korea, Republic of
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Complicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections, Community-Acquired Bacterial Pneumonia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT01072539
Pfizer
Completed
Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment
A Post-marketing Surveillance (Pms) Study Of Safety And Effectiveness In Patients With Tigecycline Treatment
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
General Hospitals
  • Complicated Skin and Skin Structure Infections
  • Complicated Intra-abdominal Infections
  • Community-Acquired Bacterial Pneumonia
Drug: tigecycline
As prescribed by physician in usual clinical practice
Other Name: Tygacil
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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3172
April 2015
April 2015   (Final data collection date for primary outcome measure)

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:

  • Complicated skin and skin structure infections
  • Complicated intra-abdominal infections
  • Community-acquired bacterial pneumonia

Exclusion Criteria:

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
Not Provided
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01072539
3074X1-4527
B1811040 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2016

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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