Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

NCT01072539

Last updated date
Study Location
Ajou University Hospital
Suwon, Gyeonggi-do, 443-380, Korea, Republic of
Contact
1-800-718-1021

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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

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Complicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections, Community-Acquired Bacterial PneumoniaStudy Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment NCT01072539
  1. Suwon, Gyeonggi-do
  2. Yangsan-si, Gyeongnam
  3. Namdong-gu, Incheon
  4. Iksan-si, Jeollabuk-do
  5. Jeonju, Jeollabuk-do
  6. Dobong-Gu, Seoul
  7. Busan,
  8. Busan,
  9. Cheongju-si,
  10. Daegu,
  11. Daegu,
  12. Daegu,
  13. Daegu,
  14. Daegu,
  15. Gyeonggi-do,
  16. Gyeonggi-do,
  17. Incheon,
  18. Incheon,
  19. Jeju,
  20. Kangwon-do,
  21. Seoul,
  22. Seoul,
  23. Seoul,
  24. Seoul,
  25. Seoul,
  26. Seoul,
  27. Seoul,
  28. Seoul,
  29. Seoul,
  30. Seoul,
  31. Seoul,
  32. Seoul,
  33. Seoul,
  34. Seoul,
  35. Seoul,
  36. Ulsan,
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Advanced Information
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
  • Complicated Skin and Skin Structure Infections
  • Complicated Intra-abdominal Infections
  • Community-Acquired Bacterial Pneumonia
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
 (submitted: April 21, 2016)
3172
Original Estimated Enrollment
 (submitted: February 19, 2010)
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:

  • 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/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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2016