drugset / Trial / NCT06128213

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

NCT06128213

Phase 2 Unknown 13 enrolled NeuroRx, Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-03-31
Primary completion
2024-06-30
Completion
2024-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cycloserine Small molecule 487.5 mg Oral
Subject Lurasidone Small molecule 16.5 mg Oral

Indications