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.
- Actual or planned therapy with tigecycline.
- At least 18 years old.
- Hypersensitivity to antibiotics or tigecycline.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting | |||
| Official Title | 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 | |||
| 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. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Adult patients (i.e., at least 18 years old) with a verified diagnosis of complicated Intra-Abdominal Infection (cIAI) or complicated Skin and Skin Structure Infection (cSSSI), for whom the decision for Tygacil treatment had already been made. | |||
| Condition | Infection | |||
| Intervention | Drug: tigecycline 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 Name: Tygacil | |||
| Study Groups/Cohorts | A Intervention: Drug: tigecycline | |||
| Publications * |
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| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 1028 | |||
| Original Enrollment | Not Provided | |||
| Actual Study Completion Date | March 2010 | |||
| Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | Germany | |||
| Administrative Information | ||||
| NCT Number | NCT00488488 | |||
| Other Study ID Numbers | 3074A1-102045 B1811054 ( Other Identifier: Pfizer ) | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
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| PRS Account | Pfizer | |||
| Verification Date | June 2011 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
