drugset / Trial / NCT00769171

Dragon Study (the Safety and Efficacy for Treatment of Patients With Complicated Intra Abdominal Infections)

NCT00769171

Phase 3 Completed 364 enrolled Bayer
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to assess the safety and efficacy of intravenous administration Moxifloxacin (BAY 12-8039) compared to intravenous ceftriaxone and metronidazole for the treatment of patients with complicated intra abdominal infections. In view of the fact that intra abdominal infections are typically polymicrobial and are often treated empirically, the selected antibacterial agent must cover the likely spectrum of bacterial pathogens. Combination antibiotics therapy has been widely used with great success.

Timeline

Start
2005-10
Primary completion
2006-12
Completion
2007-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ceftriaxone Other / unclassified 2 g Intravenous
Comparator Metronidazole Small molecule 500 mg Intravenous
Subject Moxifloxacin Small molecule 400 mg Intravenous