NCT Number: NCT00488488
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.
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Notify Me18 year and older
All sexes
Observational
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Tygacil
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to End of Treatment (up to Day 47)
Percentage of participants who received each antibiotic administered as combination therapy with tigecycline.
Time frame: Baseline to End of Treatment (up to Day 47)
Reasons for change in antibiotic treatment from Tygacil to another antibiotic.
Time frame: Baseline to End of Treatment (up to Day 47)
Time frame: Baseline to End of Treatment (up to Day 47)
Deaths for any reasons occurring during the study observation period.
Pfizer
Industry
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
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