Antibiotic Resistant Infection, UTI - Lower Urinary Tract Infection
Conditions
Brief summary
This is a prospective, Phase 4, open label, multi-center study of the clinical and microbiologic efficacy of ciprofloxacin for the treatment of uncomplicated urinary tract infections in adult women.
Interventions
DRUGCiprofloxacin
Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI.
Sponsors
Iterum Therapeutics, International Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label study of ciprofloxacin for uncomplicated urinary tract infection
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female patients ≥18 years of age with more than 24 hours of urinary symptoms attributable to a UTI 2. Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain, gross hematuria 3. A mid-stream urine specimen with: 1. a dipstick analysis positive for nitrite AND 2. a dipstick analysis positive for leukocyte esterase 4. Has given written informed consent to participate in the study.
Exclusion criteria
1. Presence of signs and symptoms suggestive of acute pyelonephritis: fever (temperature \> 38°Celsius), chills, costovertebral angle tenderness, flank pain, nausea and/or vomiting 2. Receipt of prior effective antibacterial drug therapy for uUTI for the presenting illness unless the recovered pathogen demonstrates resistance to initial antibiotic and clinical symptoms persist 3. Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in patients with uUTI 4. Patients with ileal loops or urinary stoma 5. Patients with an indwelling urinary catheter in the previous 30 days 6. Patients with paraplegia 7. Patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uUTI (e.g., patients with vesico-ureteral reflux) 8. Any history of trauma to the pelvis or urinary tract 9. Patient's urine culture results, if available at study entry, identify more than 2 microorganisms regardless of colony count or patient has a potential fungal pathogen 10. Patient's urine culture results, if available at study entry, identifies the causative uropathogen for the presenting illness to be resistant to ciprofloxacin 11. Patient has severe chronic kidney disease, or is receiving hemodialysis or peritoneal dialysis or had a renal transplant 12. Patient is known to have severe neutropenia 13. Patient is known to be pregnant 14. Patients with uncontrolled diabetes mellitus 15. Patients with a known history of myasthenia gravis 16. Patients who require concomitant administration of tizanidine 17. Patients with a history of allergy to quinolones 18. Patient is considered unlikely to survive the study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Combined Clinical and Microbiologic Response | From start of treatment until assessment of cure, approximately 12 days | Clinical response is defined as complete resolution of uUTI symptoms at entry and no new uUTI symptoms; microbiologic success is defined as eradication of baseline pathogen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiologic Response | From start of treatment until assessment of cure, approximately 12 days | Microbiologic response is defined as demonstrating \<1000 colony-forming units per mL of the baseline uropathogen at the test of cure visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ciprofloxacin Ciprofloxacin for the treatment of uncomplicated urinary tract infection
Ciprofloxacin: Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI. | 250 |
| Total | 250 |
Baseline characteristics
| Characteristic | Ciprofloxacin |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 43 Participants |
| Age, Categorical Between 18 and 65 years | 205 Participants |
| Age, Continuous | 47.3 years STANDARD_DEVIATION 16.59 |
| Body-mass index | 29.01 kg/m^2 STANDARD_DEVIATION 6.861 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 147 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 42 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 202 Participants |
| Region of Enrollment United States | 250 participants |
| Sex: Female, Male Female | 250 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 242 |
| other Total, other adverse events | 0 / 242 |
| serious Total, serious adverse events | 0 / 242 |
Outcome results
Primary
Number of Subjects With Combined Clinical and Microbiologic Response
Clinical response is defined as complete resolution of uUTI symptoms at entry and no new uUTI symptoms; microbiologic success is defined as eradication of baseline pathogen
Time frame: From start of treatment until assessment of cure, approximately 12 days
Population: Microbiological modified intent to treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ciprofloxacin | Number of Subjects With Combined Clinical and Microbiologic Response | 70 Participants |
Secondary
Microbiologic Response
Microbiologic response is defined as demonstrating \<1000 colony-forming units per mL of the baseline uropathogen at the test of cure visit
Time frame: From start of treatment until assessment of cure, approximately 12 days
Population: Microbiological modified intent to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ciprofloxacin | Microbiologic Response | 96 Participants |