A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting

Condition(s) targeted: Infection

Intervention: tigecycline (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Percentage of Participants With Clinical and Microbiological Cure: All Participants

Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections

Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections

Percentage of Participants With Composite Cure: All Participants

Percentage of Participants With Composite Cure: Nosocomial Infections

Percentage of Participants With Composite Cure: Community-acquired Infections

Secondary outcome:

Participants With Probable Failure at Follow-up

Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure

Antibiotic Agents Chosen for Combination Therapy With Tigecycline

Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic

Reasons for Utilization of Tygacil

Overall Mortality: All Participants

Detailed description: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Actual or planned therapy with tigecycline.

- At least 18 years old.

Exclusion Criteria:

- Hypersensitivity to antibiotics or tigecycline.

To obtain contact information for a study center near you, click here.

Starting date: November 2006
Last updated: July 20, 2011