Community Acquired Infections Clinical Trial
Official title:
Tigecycline In-Vitro Surveillance Study In Taiwan
In-vitro surveillance study of tigecycline (Tygacil) in Taiwan.
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | Pfizer Investigational Site | Taipei | Taiwan |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer |
China,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00035269 -
New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)
|
Phase 3 |