Tigecycline In-Vitro Surveillance Study In Taiwan

Wyeth

Status: Completed

Conditions: Community Acquired Infections

Treatments: Other: In-vitro testing

Study type: Observational

Funder types: Industry

Identifiers

NCT00488397

B1811055 (Other Identifier)

3074A1-102091

Details and patient eligibility

About

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

Enrollment: 7,902 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

7,902 participants in 1 patient group

1

Treatment:

Other: In-vitro testing