Clinical Trial: Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects With Complicated Intra-abdominal Infection
Brief Summary: This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).
Detailed Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Current Primary Outcome: Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: up to 6 weeks ]
Original Primary Outcome: Clinical response in the clinically evaluable population at the Test-of-Cure visit.
Current Secondary Outcome:
- Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit [ Time Frame: up to 6 weeks ]ME population were subjects who were clinically evaluable and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.
- Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit [ Time Frame: up to 6 weeks ]Microbiological response was assessed at patient level was the combined responses for all baseline isolates identified in intra-abdominal and blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=No sample for culture, clinical response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=No sample available for culture, clinical response was failure; Superinfection=culture from primary infection site with new isolate not identified at baseline, clinical response was failure.
- Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure [ Time Frame: up to 6 weeks ]Healthcare resource utilization assessment included days of overall inpatient hospitalization, days of primary inpatient hospitalization, days of Intensive Care Unit (ICU) treatment and days of non-ICU inpatient hospitalization
Original Secondary Outcome:
- To compare the microbiological efficacy of tigecycline to ceftriaxone plus metronidazole in the microbiologically evaluable population
- To evaluate in vitro susceptibility data on tigecycline for a range of pathogenic bacteria that cause cIAI
- To compare health care utilization between treatment groups
Information By: Wyeth is now a wholly owned subsidiary of Pfizer
Dates:
Date Received: September 30, 2005
Date Started: October 2005
Date Completion:
Last Updated: February 20, 2013
Last Verified: February 2013