Urinary Tract InfectionsPhase 2NCT06128213
NRX-101 for Complicated Urinary Tract Infection (UTI) Including Pyelonephritis
A Phase 2 study testing NRX101 (a fixed dose combination of D-cycloserine (DCS) and lurasidone HCl (lurasidone)) in people with Urinary Tract Infections and Pyelonephritis, run by NeuroRx, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections, Pyelonephritis
- What is being tested?
- NRX101 (a fixed dose combination of D-cycloserine (DCS) and lurasidone HCl (lurasidone))
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2024to 30 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- -
Who cannot join
- 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.
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- 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.
- Significantly abnormal laboratory values (usually defined as 2x normal such as for liver function tests) or any other medical abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of study data.
- Lifetime history of any of the following: surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder (e.g., Alzheimer's Disease, Parkinson's Disease), epilepsy, mental retardation, or any other disease/procedure/accident/intervention that, according to the clinician, is deemed associated with significant injury to, or malfunction of, the CNS.
- Other medical disease such as clinically significant congestive heart failure, septic shock, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy.
- Current or recent (<4 weeks) use of recreational drugs.
- History of alcohol abuse within last six months
- Pregnant or lactating.
- Evidence of immunocompromise including human immunodeficiency virus (HIV) infection, systemic or hematological malignancy requiring chemotherapeutic or radiation/immunologic interventions, immunosuppressive therapy, including maintenance corticosteroid therapy (>40 mg/day equivalent prednisolone for 5 days or more in the 30 days prior to randomization).
- Have a documented history of any moderate or severe hypersensitivity or allergic reaction to D-cycloserine, lurasidone, or both.
- Lactose allergy
- Ongoing participation in another clinical research study involving an investigational product or having received another investigational product within the last 30 days.
About this study
Official title: An Open Label Study of NRX-101 for Patients With Acute Complicated Urinary Tract Infection Including Pyelonephritis
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?
Read more
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
- Being tested
- NRX101 (a fixed dose combination of D-cycloserine (DCS) and lurasidone HCl (lurasidone))
- Medical subject headings
- Urinary Tract Infections, Pyelonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: NRX101 (a fixed dose combination of D-cycloserine (DCS) and lurasidone HCl (lurasidone)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiologic Response
Number of Participants with Microbiologic Response at the Test-of-Cure (TOC) Visit
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start31 Mar 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128213
- Sponsor's protocol ID
- NRX101-010
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of NRX-101 for Patients With Acute Complicated Urinary Tract Infection Including Pyelonephritis
- ClinicalTrials.gov ID
- NCT06128213
- Acronym / sponsor ID
- NRX101-010
- Conditions
- Urinary Tract Infections, Pyelonephritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- NeuroRx, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NRX101 Treatment arem | Experimental | 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female, age 18 years or older (no racial/ethnic restrictions).
- Urine specimen with evidence of pyuria:
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | NRX101 Treatment arem |
Primary outcome
Microbiologic Response
Time frame: Day 14
Number of Participants with Microbiologic Response at the Test-of-Cure (TOC) Visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NRX101 (a fixed dose combination of D-cycloserine (DCS) and lurasidone HCl (lurasidone)) in people with Urinary Tract Infections and Pyelonephritis, run by NeuroRx, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiologic Response (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.