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

July 20, 2011 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

1028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Hypersensitivity to antibiotics or tigecycline.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • Tygacil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.
End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
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)
Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.
End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
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)
Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.
End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)
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)
Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.
End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
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)
Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.
End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
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)
Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.
End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants With Probable Failure at Follow-up
Time Frame: Follow-up (up to Day 47)
Participants with antibiogram follow-up due to treatment failure who had detectable pathogens. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.
Follow-up (up to Day 47)
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Time Frame: Follow-up (up to Day 47)
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.
Follow-up (up to Day 47)
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
Time Frame: Baseline to End of Treatment (up to Day 47)
Percentage of participants who received each antibiotic administered as combination therapy with tigecycline.
Baseline to End of Treatment (up to Day 47)
Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic
Time Frame: Baseline to End of Treatment (up to Day 47)
Reasons for change in antibiotic treatment from Tygacil to another antibiotic.
Baseline to End of Treatment (up to Day 47)
Reasons for Utilization of Tygacil
Time Frame: Baseline to End of Treatment (up to Day 47)
Baseline to End of Treatment (up to Day 47)
Overall Mortality: All Participants
Time Frame: Baseline to End of Treatment (up to Day 47)
Deaths for any reasons occurring during the study observation period.
Baseline to End of Treatment (up to Day 47)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 18, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimate)

June 20, 2007

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3074A1-102045
  • B1811054 (Other Identifier: Pfizer)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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