Tigecycline In-Vitro Surveillance Study In Taiwan

Community Acquired Infections Clinical Trial

Official title:

Tigecycline In-Vitro Surveillance Study In Taiwan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488397
• Other study ID #: 3074A1-102091
• Secondary ID: B1811055
• Status: Completed
• Phase: N/A
• First received: June 18, 2007
• Last updated: March 21, 2011
• Start date: August 2006
• Est. completion date: February 2011

Study information

• Verified date: March 2011
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7902
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Community Acquired Infections
• Community-Acquired Infections

Intervention

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.

Locations

Country	Name	City	State
China	Pfizer Investigational Site	Taipei	Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prior to 2009: Susceptibility data of minimum inhibitory concentration (MIC), MIC50, MIC90by pathogen, tested by E-test.		in vitro study therefore not applicable	No
Primary	Post-2009: Susceptibility data of MIC, MIC50, MIC90 by pathogen, tested by micro-dilution method		in vitro study therefore not applicable	No
Secondary	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	No
Secondary	Post-2009: Susceptibility data of inhibition zone diameter (mm) by pathogen, tested by paper disc.		in vitro study therefore not applicable	No

External Links

•   To obtain contact information for a study center near you, click here.