Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01072539
First received: February 17, 2010
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

The primary objective of this study is to identify any changes on the safety profile of adverse events and serious adverse events. And the secondary objective is to evaluate clinical response in the clinically evaluable population at test-of cure (TOC) or at the end of treatment (EOT) assessment, and microbiologic response at the subject level, if available.


Condition Intervention Phase
Complicated Skin and Skin Structure Infections
Complicated Intra-abdominal Infections
Community-Acquired Bacterial Pneumonia
Drug: tigecycline
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Post-Marketing Surveillance (PMS) Study Of Safety And Effectiveness In Patients With Tigecycline Treatment

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Count and frequency of occurrence of serious adverse event or unexpected adverse event by category [ Time Frame: 5 days to 2 weeks ] [ Designated as safety issue: Yes ]
  • Count and frequency of occurrence of adverse events by patient baseline factor and by treatment factor to determine factors affecting the safety [ Time Frame: 5 days to 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical response of cure, (improvement), failure, or unevaluable in patients treated with Tygacil for the first time assessed by the investigator at the EOT(end of treatment) or TOC(test of cure) visit for each subject [ Time Frame: 5 days to 2 weeks ] [ Designated as safety issue: No ]
    Clinical response of cure, improvement, failure, or unevaluable in patients with complicated skin and skin structure infections, and clinical response of cure, failure, or unevaluable in patients with complicated intra-abdominal infections and community-acquired bacterial pneumonia

  • A microbiologic response at the subject level, if available [ Time Frame: 5 days to 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 742
Study Start Date: May 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients who have approved indications of Tygacil

Approved indications of Tygacil

-complicated intraabdominal infection, complicated skin and skin structure infection, community-acquired bacterial pneumonia

Drug: tigecycline
As prescribed by physician in usual clinical practice
Other Name: Tygacil

Detailed Description:

Prior to the conduct of this study, the investigator will explain the study objective, etc to prospective subjects on the basis of "explanatory material." The informed consent will be obtained in written form by each subject voluntarily.

  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

General Hospitals

Criteria

Inclusion Criteria:

Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :

Adults 18 years of age or older, who have one of the followings:

  • Complicated skin and skin structure infections
  • Complicated intra-abdominal infections
  • Community-acquired bacterial pneumonia

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

  • Patients who have known hypersensitivity to tigecycline
  • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
  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: NCT01072539

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01072539     History of Changes
Other Study ID Numbers: 3074X1-4527, B1811040
Study First Received: February 17, 2010
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
infection
Tygacil
PMS

Additional relevant MeSH terms:
Communicable Diseases
Infection
Intraabdominal Infections
Pneumonia, Bacterial
Bacterial Infections
Lung Diseases
Pneumonia
Respiratory Tract Diseases
Respiratory Tract Infections
Tigecycline
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014