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
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: 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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014