Tigecycline In-Vitro Surveillance Study In Taiwan

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00488397
First received: June 18, 2007
Last updated: March 21, 2011
Last verified: March 2011
  Purpose

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


Condition Intervention
Community Acquired Infections
Other: In-vitro testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tigecycline In-Vitro Surveillance Study In Taiwan

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Post-2009: Susceptibility data of MIC, MIC50, MIC90 by pathogen, tested by micro-dilution method [ Time Frame: in vitro study therefore not applicable ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Post-2009: Susceptibility data of inhibition zone diameter (mm) by pathogen, tested by paper disc. [ Time Frame: in vitro study therefore not applicable ] [ Designated as safety issue: No ]

Enrollment: 7902
Study Start Date: August 2006
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Other: In-vitro testing
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

hospital or community acquired infection

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488397

Locations
China, Taiwan
Pfizer Investigational Site
Taipei, Taiwan, China, 100
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00488397     History of Changes
Other Study ID Numbers: 3074A1-102091, B1811055
Study First Received: June 18, 2007
Last Updated: March 21, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Tygacil
microdilution method
Tigecycline
In-Vitro

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

ClinicalTrials.gov processed this record on April 22, 2014