Phase 4
N=467
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
Appendicitis · Cholecystitis · Cross Infection · Diverticulitis · Peritonitis
Bottom Line
View on ClinicalTrials.gov: NCT00195351 ↗Enrolled (actual)
467
Serious AEs
—
Results posted
Jun 2009
Primary outcome: Primary: Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit. — 133; 139 participants — p=0.009
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- tigecycline (Drug); ceftriaxone sodium + metronidazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit. |
133; 139 | 0.009 sig |
| SECONDARY Number of Microbiologically Evaluable Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit. |
91; 96 | 0.020 sig |
| SECONDARY Number of Patients by Microbiologic Response at Test-of-Cure (TOC) Visit. |
94; 98; 44; 39; 7; 3 | 0.015 sig |
Summary
This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be included for enrollment. Subjects will be stratified at randomization for Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score 10. 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 over 100.4°F (38.0°C) or high white blood cell count plus other symptoms such as nausea, vomiting, abdominal pain.
Exclusion Criteria
- Cancer
- Medicines that suppress the immune system
- Dialysis
Data sourced from ClinicalTrials.gov (NCT00195351). 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.