NCT03445195View on ClinicalTrials.gov

Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections

PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 17, 2018

Primary Completion Date

May 17, 2018

Study Completion Date

May 17, 2018

Conditions
Complicated Urinary Tract InfectionAcute Pyelonephritis
Interventions
DRUG

Sulbactam-ETX2514

The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.

DRUG

Placebo

Matching 1g IV solution.

DRUG

Imipenem-cilastatin

All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.

Trial Locations (4)

1431

Universeity Multiprofile Hospital for Active Teatment, Sofia

University Multiprofile Hospital for Active Teatment-Clinic of Nephrology, Sofia

1606

Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov, Sofia

1632

Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Doverie, Sofia

Sponsors
All Listed Sponsors
lead

Entasis Therapeutics

INDUSTRY

NCT03445195 - Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections | Biotech Hunter | Biotech Hunter