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

NCT06128213 | Unknown Phase 2 FDA Drug

• 1 other identifier: NRX101-010
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Microbiologic Response

  Number of Participants with Microbiologic Response at the Test-of-Cure (TOC) Visit

  Day 14

Study Arms (1)

NRX101 Treatment arem

EXPERIMENTAL

oral NRX-101 (a fixed dose combination of 487.5 mg D-cycloserine (DCS) and 16.5 mg lurasidone HCl (lurasidone)

Drug: NRX101 (a fixed dose combination of D-cycloserine (DCS) and lurasidone HCl (lurasidone))

Interventions

NRX101 (a fixed dose combination of D-cycloserine (DCS) and lurasidone HCl (lurasidone)) DRUG

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

NRX101 Treatment arem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18 years or older (no racial/ethnic restrictions).
• Urine specimen with evidence of pyuria:
• Dipstick analysis positive (at least trace) for leukocyte esterase OR
• Dipstick analysis positive (at least trace) for nitrates OR
• At least 10 white blood cells (WBCs) per cubic millimeter OR
• At least 10 WBCs per high power field.
• Urine culture positive for E. coli, Pseudomonas, Acinetobacter, Staphylococcus, or Klebsiella that is resistant to at least one first-line antibiotic.
• Must agree to use an effective method of birth control in sexually active men and women while taking the study drug and for one week thereafter. Barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (IUD's), hormonal contraceptives, oral contraceptive pills, surgical sterilization, and complete abstinence are examples of effective methods of contraception.
• Agrees to refrain from ethanol consumption during the study.
• Must sign an informed consent document after complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate.

You may not qualify if:

• In the judgment of the investigator, the subject requires hospitalization.
• Uncomplicated lower UTI.
• Receipt of effective antibacterial drug therapy for cUTI for a continuous duration of more than 48 hours during the 72 hours prior to Screening.
• Any recent (\<4 weeks) history of trauma to the pelvis or urinary tract.
• Concomitant infection that requires non-study systemic antibacterial therapy effective against cUTI in addition to study drug.
• Intractable UTI infection at baseline that the investigator anticipates would require \>14 days of study drug therapy.
• Suspected or confirmed prostatitis, epididymitis.
• Renal transplantation, urinary diversion of any type, or known vesico-ureteral reflux.
• Have complete, permanent obstruction of the urinary tract.
• Confirmed fungal UTI (with ≥103 fungal CFU/mL).
• Suspected or confirmed perinephric or intrarenal abscess.
• Have an indwelling urinary catheter that is considered unsafe or contraindicated to remove. Note: Indwelling urinary catheters that have been in place for \>24 hours prior to Screening must be removed and replaced prior to sample collection.
• Percutaneous nephrostomy tube
• Indwelling ureteral stent
• Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period.

Sponsors & Collaborators

• NeuroRx, Inc.: lead

MeSH Terms

Conditions

Urinary Tract Infections; Pyelonephritis

Interventions

Cycloserine; Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephritis, Interstitial; Nephritis; Kidney Diseases; Pyelitis

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Thiazoles; Sulfur Compounds; Organic Chemicals; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: March 31, 2024
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-11