Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

Study Overview
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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.

Official Title
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A Post-marketing Surveillance (Pms) Study Of Safety And Effectiveness In Patients With Tigecycline Treatment

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

Intervention / Treatment
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* Drug: tigecycline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who have approved indications of Tygacil<br>Approved indications of Tygacil -complicated intraabdominal infection, complicated skin and skin structure infection, community-acquired bacterial pneumonia | Drug: tigecycline<br>* As prescribed by physician in usual clinical practice<br>* Other names: Tygacil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs | All AEs reported after start of administration of Tygacil were considered as on treatment and summarized. All AEs, except for those with causal relationship to the study drug assessed as unlikely, were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the approved local product document and confirmed by Pfizer. | From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. | 
| Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Baseline and treatment characteristics included: prospectively/retrospectively collected data, geriatric status (<65 years or >=65 years), age categories, sex, duration of disease, infection site, severity of infection, general, present and past medical history, kidney disorder, liver disorder, total administration period of Tygacil, mean daily dose of Tygacil, past medication and therapy, and concomitant medications. | From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment | Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as effective to the treatment of Tygacil . | At the TOC or EOT assessment | 
| Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site | Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as effective to the treatment of Tygacil . | At the TOC or EOT assessment | 
| Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase) | Definitions: Eradication: None of the baseline isolates were present in a repeat culture taken from the original site of infection (documented) or a clinical response of cure precluded the availability of a specimen for culture (presumed). Persistence: Any baseline isolates were present in a repeat culture obtained from the original site of infection (documented) or culture data were not available for a participant with a clinical response of failure (presumed). Unevaluable: participants who died during therapy for non-infection-related reasons, died for any reason within 2 days after first administration of Tygacil, were lost to follow-up (ie, clinical response was not able to be assessed), or had no baseline isolates. | At the TOC or EOT assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infection, Tygacil, PMS