Tigecycline In-Vitro Surveillance Study In Taiwan

NCT00488397 | Completed

• 2 other identifiers: 3074A1-102091B1811055
• Study Type: observational
• Target: 7,902
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Community Acquired Infections

Keywords

Tygacil; microdilution method; Tigecycline; In-Vitro

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (1)

1

Other: In-vitro testing

Interventions

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.

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hospital or community acquired infection

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Taipei, Taiwan, 100, China

Location

Related Links

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

MeSH Terms

Conditions

Community-Acquired Infections

Interventions

In Vitro Techniques

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 18, 2007
• First Posted: June 20, 2007
• Study Start: August 1, 2006
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 22, 2011

Record last verified: 2011-03

Locations

CN (1)