NCT04505683

A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

A Phase 2, Randomized, Double-blind, Positive-control, Multicenter, Prospective Study to Assess Efficacy and Safety of Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Conditions

• Complicated Urinary Tract Infection Including Acute Pyelonephritis

Interventions

Type	Name	Description
DRUG	Benapenem	Benapenem for IV injection administered as a 1-gram IV infusion
DRUG	Ertapenem	Ertapenem for IV injection administered as a 1-gram IV infusion

Timeline

• Start date: 2018-12-13
• Primary completion: 2020-05-08
• Completion: 2020-05-08
• First posted: 2020-08-10
• Last updated: 2020-08-10

Locations

1 site across 1 country: China