At a glance
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A Randomized, Active-controlled Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex
In Brief
A Phase 3 clinical trial evaluating Sulbactam, Durlobactam, and 2 other interventions for Acinetobacter Baumannii-calcoaceticus Complex and 4 related conditions. Completed, enrolled 207 participants across 90 sites in 17 countries.
Detailed Summary
This is a 2-part study, with Part A being the randomized, controlled portion of the study in patients with ABC hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or bacteremia. Part B is the single-group portion of the study and includes ABC infections that are resistant to or have failed colistin or polymyxin B treatment, as detailed in the inclusion criteria.
Study Details
Timeline
Interventions
1.0 g sulbactam IV infused over 3 hours every 6 hours (q6h).
1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h). Sulbactam-Durlobactam: Treatment for 7 days up to 14 days if clinically indicated.
Treatment for 7 days up to 14 days if clinically indicated.
1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h. Treatment for 7 days up to 14 days if clinically indicated.