A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting

Study Overview
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Brief Summary
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To assess the efficacy and safety of Tygacil in the usual German hospital setting. The main goals are: to assess the efficacy of Tygacil under usual care conditions (cure rate); to assess the main side effects observed in daily medical practice (Safety of Tygacil); to determine whether patients are optimally dosed with Tygacil (according to the label) and the proportion of patients receiving a monotherapy versus combination therapy; to observe the potential resistance development against Tygacil in Germany; to determine which antibiotic agents are chosen for a combination therapy with Tygacil; to determine to which antibiotic substance non-responders to Tygacil are switched; to assess the duration of the intravenous therapy with Tygacil and to determine whether and which patients receive an oral antibiotic substance after the therapy with Tygacil; to collect information on profile, comorbidities and characteristics of patients treated with Tygacil.

Detailed Description
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Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.

Official Title
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A Non-Interventional Study To Evaluate The Safety And Effectiveness Of Tygacil In The Treatment Of Patients With Complicated Intra-Abdominal Infections Or Complicated Skin And Skin Structure Infections

Conditions
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Infection

Intervention / Treatment
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* Drug: tigecycline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Actual or planned therapy with tigecycline. At least 18 years old. Exclusion Criteria: Hypersensitivity to antibiotics or tigecycline.

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 |
| --- | --- |
| A<br> | Drug: tigecycline<br>* The patients will be treated in accordance with the requirements of the labeling of tigecycline in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.<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 Clinical and Microbiological Cure: All Participants | Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure. | End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) | 
| Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections | Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure. | End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) | 
| Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections | Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure. | End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days) | 
| Percentage of Participants With Composite Cure: All Participants | Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required. | End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) | 
| Percentage of Participants With Composite Cure: Nosocomial Infections | Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required. | End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) | 
| Percentage of Participants With Composite Cure: Community-acquired Infections | Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required. | End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Probable Failure at Follow-up | Participants with antibiogram follow-up due to treatment failure who had detectable pathogens. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy. | Follow-up (up to Day 47) | 
| Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Percentage of participants with resistant pathogens for each pathogen identified at second (follow-up) microbial examination. A second microbiological examination was documented only for participants with treatment failure. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy. | Follow-up (up to Day 47) | 
| Antibiotic Agents Chosen for Combination Therapy With Tigecycline | Percentage of participants who received each antibiotic administered as combination therapy with tigecycline. | Baseline to End of Treatment (up to Day 47) | 
| Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic | Reasons for change in antibiotic treatment from Tygacil to another antibiotic. | Baseline to End of Treatment (up to Day 47) | 
| Reasons for Utilization of Tygacil |  | Baseline to End of Treatment (up to Day 47) | 
| Overall Mortality: All Participants | Deaths for any reasons occurring during the study observation period. | Baseline to End of Treatment (up to Day 47) |