Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)

Phase 4

Completed

• Conditions: Appendicitis; Cholecystitis; Diverticulitis; Intra-Abdominal Abscess; Intra-Abdominal Infection; Peritonitis
• Interventions: Drug: tigecycline; Drug: ceftriaxone plus metronidazole

• Registration Number: NCT00230971
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 Description

Not available

Study Timeline

• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-09-30
• Study Start: 2005-10
• Study First Posted: 2005-10-03
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2009-09-30
• Results First Submitted QC: 2010-04-05
• Results First Posted: 2010-04-26
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 473

Inclusion Criteria

• Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
• Fever plus other symptoms such as nausea, vomiting, abdominal pain.

Exclusion Criteria

• Cancer
• Medicines that suppress the immune system
• Dialysis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	tigecycline	-
B	ceftriaxone plus metronidazole	-

Primary Outcome Measures

Name	Time	Method
Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit	up to 6 weeks	CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made. Clinical response was assigned by investigator per protocol-specified guidelines and defined as: test article and initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection. TOC performed 10-28 days after last dose of study drug.

Secondary Outcome Measures

Name	Time	Method
Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit	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	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	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