At a glance
ClinicalIndex Comparison Record- ✓Clinical diagnosis of complicated intra-abdominal infection requiring surgery within 24 hours
- ✓Fever ≥100.4°F (38.0°C) or elevated white blood cell count plus symptoms such as nausea, vomiting, or abdominal pain
- ✕Active cancer
- ✕Concurrent use of medicines that suppress the immune system
- ✕Dialysis dependence
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating tigecycline and ceftriaxone sodium + metronidazole for Appendicitis and 4 related conditions. Completed, enrolled 467 participants across 66 sites in 6 countries.
Detailed 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 and \> 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).
Study Details
Timeline
Interventions
every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.