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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00488488
First received: June 18, 2007
Last updated: July 20, 2011
Last verified: June 2011
  Purpose

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
Infection
Drug: tigecycline

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Clinical and Microbiological Cure: All Participants [ Time Frame: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) ] [ Designated as safety issue: No ]
    Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.

  • Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections [ Time Frame: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) ] [ Designated as safety issue: No ]
    Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.

  • Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections [ Time Frame: End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days) ] [ Designated as safety issue: No ]
    Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.

  • Percentage of Participants With Composite Cure: All Participants [ Time Frame: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) ] [ Designated as safety issue: No ]
    Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.

  • Percentage of Participants With Composite Cure: Nosocomial Infections [ Time Frame: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) ] [ Designated as safety issue: No ]
    Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.

  • Percentage of Participants With Composite Cure: Community-acquired Infections [ Time Frame: End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days) ] [ Designated as safety issue: No ]
    Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.


Secondary Outcome Measures:
  • Participants With Probable Failure at Follow-up [ Time Frame: Follow-up (up to Day 47) ] [ Designated as safety issue: No ]
    Participants with antibiogram follow-up due to treatment failure who had detectable pathogens. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.

  • Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure [ Time Frame: Follow-up (up to Day 47) ] [ Designated as safety issue: No ]
    Percentage of participants with resistant pathogens for each pathogen identified at second (follow-up) microbial examination. A second microbiological examination was documented only for participants with treatment failure. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.

  • Antibiotic Agents Chosen for Combination Therapy With Tigecycline [ Time Frame: Baseline to End of Treatment (up to Day 47) ] [ Designated as safety issue: No ]
    Percentage of participants who received each antibiotic administered as combination therapy with tigecycline.

  • Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic [ Time Frame: Baseline to End of Treatment (up to Day 47) ] [ Designated as safety issue: No ]
    Reasons for change in antibiotic treatment from Tygacil to another antibiotic.

  • Reasons for Utilization of Tygacil [ Time Frame: Baseline to End of Treatment (up to Day 47) ] [ Designated as safety issue: No ]
  • Overall Mortality: All Participants [ Time Frame: Baseline to End of Treatment (up to Day 47) ] [ Designated as safety issue: No ]
    Deaths for any reasons occurring during the study observation period.


Enrollment: 1028
Study Start Date: November 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A 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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Hypersensitivity to antibiotics or tigecycline.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488488

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00488488     History of Changes
Other Study ID Numbers: 3074A1-102045, B1811054
Study First Received: June 18, 2007
Results First Received: March 29, 2011
Last Updated: July 20, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Intraabdominal Infections
Infection
Tigecycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014