NRX-101 for Complicated Urinary Tract Infection (UTI) Including Pyelonephritis (NCT06128213) | Clinical Trial Compass
UnknownPhase 2
NRX-101 for Complicated Urinary Tract Infection (UTI) Including Pyelonephritis
13 participantsStarted 2024-03-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.