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 range18 Years
SexALL
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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.
Exclusion criteria
✕. In the judgment of the investigator, the subject requires hospitalization.