Tygacil Drug Use Investigation

Study Overview
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Brief Summary
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Secondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese medical practice

Official Title
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Tygacil Drug Use Investigation (Tigecycline Evaluation Study For Safety And Effectiveness In Patient Infected With Multi-Drug Resistance.)

Conditions
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Intra-Abdominal Infections, Skin Disease, Infectious

Intervention / Treatment
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* Drug: Tigecycline (Tygacil)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who are prescribed tigecycline (Tygacil). Exclusion Criteria: Subject who have not been prescribed tigecycline (Tygacil).
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 |
| --- | --- |
| Tigecycline (Tygacil)<br>Subjects who are treated with tigecycline | Drug: Tigecycline (Tygacil)<br>* Tigecycline 50 mg intravenously. Therapy conducted according to Japanese LPD of Tygacil. Tygacil will be dosed according to labeling. The administration and duration of the therapy will be determined by the treating physician to meet the patient individual needs for treatment.<br>* Other names: Tygacil, Tigecycline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Drug Reaction (ADR) | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Tygacil in a participant who received Tygacil. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Tygacil was assessed by the physician. | Up until 14 days from the start date and 28 days from the end of the observation period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response Rate | Clinical response rate, which was defined as the percentage of participants who achieved clinical response as effective over the total number of assessable effectiveness analysis population(effective plus ineffective,) was presented along with two-sided 95% CI. Clinical response of Tygacil was assessed as effective, ineffective, or indeterminate by the physician at the end of observation period. Overall response of Tygacil was determined by the physician based on laboratory and clinical findings without bacteriological findings. | Within 14 days from the start date | 
| Clinical Response Rate of Cure | The cure rate, which was defined as the percentage of participants who were assessed as cure over the total number of assessable effectiveness analysis population (cure plus failure), was presented along with two-sided 95% CI. Clinical response of cure was assessed as cure, failure, or indeterminate by the physician within 28 days post-treatment. | Within 28 days post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tygacil, Tigecycline, Post marketing surveillance, Japanese, Infection