Tigecycline In-Vitro Surveillance Study In Taiwan

In-vitro surveillance study of tigecycline (Tygacil) in Taiwan.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7902

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Taiwan
      • Taipei, Taiwan, China, 100
        • Pfizer Investigational Site

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

hospital or community acquired infection

Description

Inclusion Criteria:

  • Clinically relevant causative isolate (no duplicates) - The isolate must meet the laboratory criteria of "significant pathogen" and be considered the "probable causative agent" of a hospital or community acquired infection.
  • Sources - All body sites are acceptable clinical sources for isolates to be included in this study (Intra-abdominal infection, tracheal secretion/bronchoalveolar lavage, blood culture, wound smear). However, no more than 10 % of all isolates can come from urine cultures.
  • Within study group - Only isolates defined by the protocol are to be included.

Exclusion Criteria:

  • Limited isolates from sources - No more than 10 % of all isolates from this study will be derived from urine cultures.
  • No banked or stored isolates.
  • No duplicate isolates - Only one isolate per patient is permitted.
  • Outside study group - Any isolate other than those defined by protocol.

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
1
This is an in-vitro study thus only one group in the study and there is no intervention treatment nor procedure involved in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prior to 2009: Susceptibility data of minimum inhibitory concentration (MIC), MIC50, MIC90by pathogen, tested by E-test.
Time Frame: in vitro study therefore not applicable
in vitro study therefore not applicable
Post-2009: Susceptibility data of MIC, MIC50, MIC90 by pathogen, tested by micro-dilution method
Time Frame: in vitro study therefore not applicable
in vitro study therefore not applicable

Secondary Outcome Measures

Outcome Measure
Time Frame
Prior to 2009: 1. Susceptibility data of minimum inhibitory concentration (MIC), MIC50, MIC90 by pathogen, tested by micro-dilution method 2. Susceptibility data of inhibition zone diameter(mm) by pathogen, tested by paper disc.
Time Frame: in vitro study therefore not applicable
in vitro study therefore not applicable
Post-2009: Susceptibility data of inhibition zone diameter (mm) by pathogen, tested by paper disc.
Time Frame: in vitro study therefore not applicable
in vitro study therefore not applicable

Collaborators and Investigators

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

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.

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

August 1, 2006

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

June 18, 2007

First Submitted That Met QC Criteria

June 18, 2007

First Posted (Estimate)

June 20, 2007

Study Record Updates

Last Update Posted (Estimate)

March 22, 2011

Last Update Submitted That Met QC Criteria

March 21, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3074A1-102091
  • B1811055 (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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