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

NCT06128213 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-11-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • NeuroRx, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2024-06-30
Completion
2024-09-30
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06128213 on ClinicalTrials.gov