Phase 4
N=473
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
Appendicitis · Cholecystitis · Diverticulitis · Intra-Abdominal Abscess · Intra-Abdominal Infection
Bottom Line
View on ClinicalTrials.gov: NCT00230971 ↗Enrolled (actual)
473
Serious AEs
16.1%
Results posted
Apr 2010
Primary outcome: Primary: Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit — 162; 150 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- tigecycline (Drug); ceftriaxone plus metronidazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit |
162; 150 | — |
| SECONDARY Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit |
97; 86 | 0.001 sig |
| SECONDARY Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit |
98; 86; 21; 22; 3; 0 | — |
| SECONDARY Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure |
13.03; 12.69; 12.62; 12.16; 8.24; 6.14 | 0.750 |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00230971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.