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

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NCT00488488

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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.

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Advanced Information
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 *

*   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
 (submitted: November 24, 2010)		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:

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

Exclusion Criteria:

  • Hypersensitivity to antibiotics or tigecycline.
Sex/Gender
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2011