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

University of Iowa35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Uncomplicated Bacterial Cystitis

Interventions

Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 daysDRUG

ciprofloxacin 250 mg BID x 3 daysDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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