NCT03445195

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

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Entasis Therapeutics · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with complicated urinary tract infections (cUTIs) who are otherwise relatively healthy.

Detailed description

This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with cUTIs who are otherwise relatively healthy. Patients with Acute Pyelonephritis may also be enrolled. Approximately 80 patients will be randomized to receive either 1 g ETX2514/1 g sulbactam IV or matching placebo every 6 hours (q6h). All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.

Conditions

• Complicated Urinary Tract Infection
• Acute Pyelonephritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-17
• Primary completion: 2018-05-17
• Completion: 2018-05-17
• First posted: 2018-02-26
• Last updated: 2020-01-22
• Results posted: 2019-06-05

Locations

4 sites across 1 country: Bulgaria

Regulatory

• FDA-regulated drug study