Gender
Female
Age Group
18 Years to 75 Years
Accepting Healthy Volunteers
No
Inclusion Criteria:
- History of UTI in the past 12 months and prior or current uUTI caused by AMR E. coli
(as single pathogen or part of polymicrobial infection where E. coli is the
predominant pathogen). Please note that the current infection can be used to meet
the requirement of AMR E. coli documentation.
- Able to supply a mid-stream, clean catch urine sample for microbiological analysis.
- Active acute uUTI infection defined by:
a. Evidence of pyuria: i. >10 white blood cell (WBC)/mL3 on microscopic evaluation
of spun, clean, mid-stream urine specimen or >3 WBC/high power field on unspun
clean, mid-stream urine specimen, AND/OR ii. Dipstick analysis of a clean,
mid-stream urine specimen positive for leukocytes, AND b. At least 2 of the
following signs or symptoms of UTI: dysuria, urinary frequency, urinary urgency, or
suprapubic pain
- Willing to comply with all aspects of study design including study restrictions,
blood, urine, and stool sampling, and scheduled study visits.
- All sexually active female patients of childbearing potential must use highly
effective contraception during the study and until 2 weeks after the last dose of
study drug treatment.
- Agrees to STOP continuous low dose antimicrobial prophylaxis and/or will maintain
the same practices for post-coital antimicrobial prophylaxis to prevent UTI, as
during the prior 12-months, for the entire study duration (throughout the 6-month
follow-up period or study discharge).
- Agrees to not use any prescription or non-prescription medication for the
microbiological or symptomatic treatment of the presenting acute uUTI for the first
10 days of the study.
- Capable of providing their own signed informed consent form (ICF) prior to any
study-related procedures being performed.
- If participating in Part 1 of the study, agrees to fast for ≥2 h prior to first dose
of study drug on Day 1/Visit 1 except for drinking 240 mL of water with study drug
administration.
Exclusion Criteria:
- Signs or symptoms of systemic illness such as fever greater than 38° Centigrade/
Celsius, shaking chills, or other clinical manifestations suggestive of complicated
UTI.
- Treatment with other antibacterial drugs including those that are effective for
treatment of the acute uUTI or prevention of recurrent UTI in the 5 days prior to
Screening unless the recovered pathogen demonstrates resistance to the initial
antibiotic and clinical symptoms persist. In postmenopausal women vaginal estrogen
replacement therapy is permitted so long as patient meets all other eligibility
criteria, that the dose and regimen has be stable for > 3 months from Screening
(D1/V1), and that there is no planned change to therapy through the 6-month
follow-up period or study discontinuation.
- Clinical symptoms for more than 5 days before Screening.
- Presence of indwelling urinary bladder catheters, urinary tract anatomical
abnormalities that increase UTI risk or lead to a post void residual (PVR) urine
volume > 150mL, poorly controlled diabetes mellitus (diagnosed but is not being
treated/managed by a physician's care or HbA1c >8), current symptomatic or larger
than 5mm renal calculi, or advanced renal dysfunction (determined by eGFR < 45
mL/min/1.73 m2). Patients with vaginal prolapse beyond the hymen with Valsalva
(e.g., when coughing).
- Individuals considered to be immunocompromised.
- Clinically significant serious unstable physical illness that in the investigator's
opinion prevents patient from completing the study or prevents interpretation or
resolution of clinical symptoms.
- Pregnant or nursing women.
- Exposure to any investigational drugs or other phage therapy 30 days prior to
Screening (D1/V1) or prior to participation in this study. Patients who participate
in Part 1 are not eligible for participation in Part 2.
- Allergies to excipients of the study drug or antibiotics.
- History of autonomic dysreflexia.
- History of intravenous (IV) drug abuse or is currently using or has positive results
for drugs of abuse at screening.
- Patients who reside in a long-term care facility.
- Suspected or confirmed acute coronavirus disease 2019 (COVID-19) or recent COVID-19
infection with ongoing symptoms.
