Uncomplicated Bacterial Cystitis
Conditions
Brief summary
Pilot study to compare the efficacy and safety of 3-day, twice-daily regimens of nitrofurantoin and ciprofloxacin in emergency department (ED) patients presenting with UBC.
Interventions
DRUGNitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
DRUGciprofloxacin 250 mg BID x 3 days
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* pre-menopausal females * ages 18-45 years old * symptoms of a UTI (dysuria, frequency, urgency)
Exclusion criteria
* Onset of symptoms \>7 days prior to the ED visit * Non-English speaking * Symptoms of pyelonephritis * Diabetic * Indications of sepsis * Immunocompromised * Currently using prophylactic antimicrobials * Medications that could interfere with study drug * Pregnant * Lactating * History of kidney or liver disease * Vaginal symptoms * Presence of a urinary catheter * Treatment for UBC \<2 weeks prior to ED visit * Known allergy to study drug * Unavailable for follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Cure at Day 7 | 7 days | Seven days after randomization, subjects received a telephone call to determine if their symptoms have completely resolved. Patients answers were limited to: Yes (clinical cure), No (treatment failure) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nitrofurantoin 100 mg Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days | 18 |
| Ciprofloxacin 250 mg ciprofloxacin 250 mg BID x 3 days | 17 |
| Total | 35 |
Baseline characteristics
| Characteristic | Nitrofurantoin 100 mg | Total | Ciprofloxacin 250 mg |
|---|---|---|---|
| Age, Continuous | 24.4 years | 24.75 years | 25.1 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 18 Participants | 35 Participants | 17 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 18 participants | 35 participants | 17 participants |
| Sex: Female, Male Female | 18 Participants | 35 Participants | 17 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 17 |
| other Total, other adverse events | 1 / 18 | 1 / 17 |
| serious Total, serious adverse events | 0 / 18 | 0 / 17 |
Outcome results
Primary
Number of Participants With Clinical Cure at Day 7
Seven days after randomization, subjects received a telephone call to determine if their symptoms have completely resolved. Patients answers were limited to: Yes (clinical cure), No (treatment failure)
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nitrofurantoin 100 mg | Number of Participants With Clinical Cure at Day 7 | 13 participants |
| Ciprofloxacin 250 mg | Number of Participants With Clinical Cure at Day 7 | 12 participants |