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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
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.
Details
| Lead sponsor | Pfizer |
|---|---|
| Status | COMPLETED |
| Enrolment | 1028 |
| Start date | 2006-11 |
| Completion | 2010-03 |
Conditions
- Infection
Interventions
- tigecycline
Primary outcomes
- Percentage of Participants With Clinical and Microbiological Cure: All Participants — End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure. - Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections — End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure. - Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections — End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)
Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure. - Percentage of Participants With Composite Cure: All Participants — End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required. - Percentage of Participants With Composite Cure: Nosocomial Infections — End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required. - Percentage of Participants With Composite Cure: Community-acquired Infections — End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)
Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.