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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | 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
Condition | Intervention | Phase |
---|---|---|
Infection |
Drug: Tygacil |
Phase IV |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | A Pharmacovigilance Evaluation and Assessment of the Prescribing Practice for Tygacil in Usual Health Care Setting |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study ID Numbers: | 102045 |
Study First Received: | June 18, 2007 |
Last Updated: | December 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00488488 |
Health Authority: | Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices |
Tigecycline |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Infection Pharmacologic Actions |