A Pilot Comparison of Short-course Nitrofurantoin in Females With Uncomplicated Bacterial Cystitis in the Emergency Department
Information source: University of Iowa
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Uncomplicated Bacterial Cystitis
Intervention: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days (Drug); ciprofloxacin 250 mg BID x 3 days (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Iowa
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: clinical cure at 7 days
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States
Additional Information
Starting date: October 2010
Last updated: December 12, 2012
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