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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
207
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.
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Chicago, Illinois, United States
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Shreveport, Louisiana, United States
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Cincinnati, Ohio, United States
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Memphis, Tennessee, United States
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Houston, Texas, United States
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Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population
The primary efficacy endpoint for the study is 28-day all-cause mortality in the CRABC m-MITT population in Part A.
Time frame: 28 Days
Proportion of Patients With Nephrotoxicity
The primary safety endpoint for the study is nephrotoxicity, as measured by the Risk-Injury-Failure-Loss-End-stage renal disease (RIFLE) criteria, in the MITT population in Part A.
Time frame: 28 days
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Brest, Belarus
Entasis Research Site
Grodno, Belarus
Entasis Research Site
Homyel, Belarus
Entasis Research Site
Minsk, Belarus
Entasis Research Site
Belo Horizonte, Brazil
...and 80 more locations