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Completed

NCT Number: NCT00488397

Tigecycline In-Vitro Surveillance Study In Taiwan

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

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Key information

Conditions

Community Acquired Infections Community-Acquired Infections Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site

Taipei, Taiwan, 100, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

In-vitro testing

Other

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.

Primary outcomes

  1. 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

  2. Post-2009: Susceptibility data of MIC, MIC50, MIC90 by pathogen, tested by micro-dilution method

    Time frame: in vitro study therefore not applicable

Secondary outcomes

  1. 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

  2. Post-2009: Susceptibility data of inhibition zone diameter (mm) by pathogen, tested by paper disc.

    Time frame: in vitro study therefore not applicable

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Jun 20, 2007
Registry last updated
Mar 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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