A Pilot Comparison of Short-course Nitrofurantoin in Females With Uncomplicated Bacterial Cystitis in the Emergency Department

University of Iowa

Status and phase: Completed; Phase 4

Conditions: Uncomplicated Bacterial Cystitis

Treatments: Drug: ciprofloxacin 250 mg BID x 3 days; Drug: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days

Study type: Interventional

Funder types: Other

Identifiers

NCT01749605

201005757

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups

nitrofurantoin 100 mg

Active Comparator group

Treatment:

Drug: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days

Ciprofloxacin 250 mg

Active Comparator group

Treatment:

Drug: ciprofloxacin 250 mg BID x 3 days