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

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NCT00488488

Last updated on April 10, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Actual or planned therapy with tigecycline.

- At least 18 years old.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Hypersensitivity to antibiotics or tigecycline.

NCT00488488
Pfizer
Completed
A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting

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A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting
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
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.
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Infection
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
A
Intervention: Drug: tigecycline


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1028
March 2010
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Actual or planned therapy with tigecycline.
  • At least 18 years old.

Exclusion Criteria:

  • Hypersensitivity to antibiotics or tigecycline.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Germany
 
NCT00488488
3074A1-102045
B1811054 ( Other Identifier: Pfizer )
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2011

FOR MORE INFORMATION

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