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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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