A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting
- Registration Number
- NCT00488488
- Lead Sponsor
- Pfizer
- Brief Summary
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
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1028
- Actual or planned therapy with tigecycline.
- At least 18 years old.
- Hypersensitivity to antibiotics or tigecycline.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A tigecycline -
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Participants With Probable Failure at Follow-up Follow-up (up to Day 47) Participants with antibiogram follow-up due to treatment failure who had detectable pathogens. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure Follow-up (up to Day 47) 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.
Antibiotic Agents Chosen for Combination Therapy With Tigecycline Baseline to End of Treatment (up to Day 47) Percentage of participants who received each antibiotic administered as combination therapy with tigecycline.
Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic Baseline to End of Treatment (up to Day 47) Reasons for change in antibiotic treatment from Tygacil to another antibiotic.
Reasons for Utilization of Tygacil Baseline to End of Treatment (up to Day 47) Overall Mortality: All Participants Baseline to End of Treatment (up to Day 47) Deaths for any reasons occurring during the study observation period.