Tigecycline In-Vitro Surveillance Study In Taiwan

Completed

• Conditions: Community Acquired Infections
• Interventions: Other: In-vitro testing

• Registration Number: NCT00488397
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-06-18
• Study First Submitted QC: 2007-06-18
• Study First Posted: 2007-06-20
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-21
• Last Update Posted: 2011-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7902

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	In-vitro testing	-

Primary Outcome Measures

Name	Time	Method
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 method	in vitro study therefore not applicable

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇳 Taipei, Taiwan, China