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Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

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NCT01072539

Last updated on November 21, 2019
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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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[email protected]

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Descriptive Information
Brief TitleStudy Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment
Official TitleA Post-marketing Surveillance (Pms) Study Of Safety And Effectiveness In Patients With Tigecycline Treatment
Brief SummaryThe 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 DescriptionPrior 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 TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationGeneral Hospitals
Condition
  • Complicated Skin and Skin Structure Infections
  • Complicated Intra-abdominal Infections
  • Community-Acquired Bacterial Pneumonia
InterventionDrug: tigecycline
As prescribed by physician in usual clinical practice
Other Name: Tygacil
Study Groups/CohortsPatients 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 StatusCompleted
Actual Enrollment
 (submitted: April 21, 2016)		3172
Original Estimated Enrollment
 (submitted: February 19, 2010)		3000
Actual Study Completion DateApril 2015
Actual Primary Completion DateApril 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:

  • 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
Sex/GenderNot Provided
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesKorea, Republic of
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01072539
Other Study ID Numbers3074X1-4527
B1811040 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2016

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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