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Tigecycline In-Vitro Surveillance Study In Taiwan

Tigecycline In-Vitro Surveillance Study In Taiwan

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00488397
Enrollment
7902
Registered
2007-06-20
Start date
2006-08-31
Completion date
2011-02-28
Last updated
2011-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community Acquired Infections

Keywords

Tygacil, microdilution method, Tigecycline, In-Vitro

Brief summary

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

Interventions

OTHERIn-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.

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime 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.in vitro study therefore not applicable
Post-2009: Susceptibility data of inhibition zone diameter (mm) by pathogen, tested by paper disc.in vitro study therefore not applicable

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026