Clinical Trials Directory

Trials / Completed

CompletedNCT03894046

Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
207 (actual)
Sponsor
Entasis Therapeutics · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGSulbactam1.0 g sulbactam IV infused over 3 hours every 6 hours (q6h).
DRUGDurlobactam1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h). Sulbactam-Durlobactam: Treatment for 7 days up to 14 days if clinically indicated.
DRUGColistinTreatment for 7 days up to 14 days if clinically indicated.
DRUGImipenem/Cilastatin 500 mg/500 mg1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h. Treatment for 7 days up to 14 days if clinically indicated.

Timeline

Start date
2019-09-05
Primary completion
2021-07-26
Completion
2021-07-26
First posted
2019-03-28
Last updated
2023-02-01
Results posted
2023-02-01

Locations

90 sites across 17 countries: United States, Belarus, Brazil, China, Greece, Hungary, India, Israel, Lithuania, Mexico, Peru, Puerto Rico, Russia, South Korea, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

Source: ClinicalTrials.gov record NCT03894046. Inclusion in this directory is not an endorsement.