Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2015-04-30

Brief Summary

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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

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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.

Conditions

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Complicated Skin and Skin Structure Infections Complicated Intra-abdominal Infections Community-Acquired Bacterial Pneumonia

Keywords

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infection Tygacil PMS

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients who have approved indications of Tygacil

Approved indications of Tygacil

-complicated intraabdominal infection, complicated skin and skin structure infection, community-acquired bacterial pneumonia

tigecycline

Intervention Type DRUG

As prescribed by physician in usual clinical practice

Interventions

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tigecycline

As prescribed by physician in usual clinical practice

Intervention Type DRUG

Other Intervention Names

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Tygacil

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Ulsan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B1811040

Identifier Type: OTHER

Identifier Source: secondary_id

3074X1-4527

Identifier Type: -

Identifier Source: org_study_id

Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Patients who have approved indications of Tygacil

tigecycline

Interventions

tigecycline

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Pfizer

Responsible Party

Principal Investigators

Pfizer CT.gov Call Center

Locations

Ajou University Hospital

Pusan National University Yangsan Hospital

Gachon University Gil Hospital

Wonkwang University Hospital

Chonbuk National University Hospital

Hanil Medical Center

Kosin University Gospel Hospital

Dong-A University Medical Center (Dong-A University Hospital)

Cheongju St. Mary's Hospital

Keimyung University Dongsan Medical Center (KUDMC)

Kyungpook National University Hospital (KNUH)

Daegu fatima hospital

Yeungnam University Medical Center

Daegu Catholic University Medical Center (DCUMC)

Korea University Ansan Hospital

Ajou University Hospital

Inha University Hospital

Gachon University Gil Hospital

Jeju National University Hospital

Yonsei University Wonju College of Medicine- Wonju Christian Hospital

Korea University Anam Hospital

Yonsei University College of Medicine Severance Hospital Rheumatology Internal Medicine

Kyunghee University Medical Hospital

Hallym University Kangdong Sacred Heart Hospital

Kyung Hee University Hospital at Gangdong

Kangdong Sacred Heart Hospital

Samsung Medical Center

Korea University Anam Hospital

Asan Medical Center, University of Ulsan

Asan Medical Center

Eulji Medical Center

Hallym University Kangnam Sacred Heart Hospital

Hallym University Medical Center (HUMC) - Kangnam Sacred Heart Hospital

Korea University Guro Hospital

Kangbuk Samsung Medical Center

Ulsan University Hospital

Countries

Related Links

Other Identifiers

B1811040

3074X1-4527