Study Evaluating Local Susceptibility Patterns Associated With Tigecycline in Comparison to Other Antibiotics

• ClinicalTrials.gov Identifier: NCT01311349
• Recruitment Status: Completed
• First Posted: March 9, 2011
• Last Update Posted: March 9, 2011
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by: Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: August 10, 2009
• First Posted Date: March 9, 2011
• Last Update Posted Date: March 9, 2011
• Study Start Date: December 2005
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Evaluating Local Susceptibility Patterns Associated With Tigecycline in Comparison to Other Antibiotics
• Official Title: Evaluation of the Antimicrobial Activity In Vitro of Tigecycline in Comparison to Other Broad Spectrum Antibiotics in Isolates Collected From Patients
• Brief Summary: Various bacterial organisms will be tested in order to compile information regarding the effectiveness of tigecycline against certain bacteria seen in local communities.
• Detailed Description: This is a prospective, microbiologic in vitro evaluation which will study the susceptibility of tigecycline in disk diffusion on clinical bacterial isolates collected from inpatients and outpatients. Fourteen hospital centers participated in the program. In vitro efficacy of tigecycline will be determined through the in vitro disk diffusion activity, using FDA breakpoints.
• Study Type: Observational
• Study Design: Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Hospitalized patients and outpatients
• Condition: Infection
• Intervention: Not Provided

Study Groups/Cohorts

1

A listing of all isolates meeting the inclusion criteria will be maintained.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 7, 2011): 1575
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2006
• Primary Completion Date: Not Provided
• Eligibility Criteria: Inclusion Criteria: Any protocol-specified microorganism isolated from the samples collected from hospitalized patients and outpatients

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01311349
• Other Study ID Numbers: 3074A1-102056
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
• Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Wyeth is now a wholly owned subsidiary of Pfizer

• PRS Account: Wyeth is now a wholly owned subsidiary of Pfizer
• Verification Date: August 2009