A Pilot Comparison of Short-course Nitrofurantoin in Females With Uncomplicated Bacterial Cystitis in the Emergency Department
Phase 4
Completed
- Conditions
- Uncomplicated Bacterial Cystitis
- Interventions
- Registration Number
- NCT01749605
- Lead Sponsor
- University of Iowa
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 35
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ciprofloxacin 250 mg ciprofloxacin 250 mg BID x 3 days - nitrofurantoin 100 mg Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days -
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States