NCT06128213

NRX-101 for Complicated Urinary Tract Infection (UTI) Including Pyelonephritis

An Open Label Study of NRX-101 for Patients With Acute Complicated Urinary Tract Infection Including Pyelonephritis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: NeuroRx, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to test NRX101 in participants with complicated urinary tract infections including pyelonephritis. The main questions it aims to answer are: * Does NRX101 help participants resolve UTIs? * Is NRX101 safe for participants with UTIs? Participants will be seen in a doctor's office approximately 6 times to: * Answer a short 10 item questionnaire. * Review of side effects * Urine tests * Blood draw (about 10 ml or 2 teaspoons) * Review of medications * Review any signs or symptoms of UTI * Vital signs and weight (including blood pressure, heart rate, respiratory rate, and temperature) * Review of medical history This is an open-label study of NRX101, which means both you and your doctor know what drug you are taking. After the study is completed, researchers will look at the data to see if NRX101 helps participants with complicated UTI's.

Conditions

• Urinary Tract Infections
• Pyelonephritis

Interventions

Type	Name	Description
DRUG	NRX101 (a fixed dose combination of D-cycloserine (DCS) and lurasidone HCl (lurasidone))	oral NRX-101 (a fixed dose combination of 487.5 mg D-cycloserine (DCS) and 16.5 mg lurasidone HCl (lurasidone) twice daily for 10 days

Timeline

• Start date: 2024-03-31
• Primary completion: 2024-06-30
• Completion: 2024-09-30
• First posted: 2023-11-13
• Last updated: 2023-11-13

Regulatory

• FDA-regulated drug study