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

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 Overview

• Status: Completed
• Conditions: Uncomplicated Bacterial Cystitis
• Intervention / Treatment: Drug: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days; Drug: ciprofloxacin 250 mg BID x 3 days

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: nitrofurantoin 100 mg	Drug: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
Active Comparator: Ciprofloxacin 250 mg	Drug: ciprofloxacin 250 mg BID x 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	7 days

Collaborators and Investigators

• Sponsor: University of Iowa

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: December 11, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (Estimate): December 13, 2012

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Cystitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Ciprofloxacin; Nitrofurantoin
• Other Study ID Numbers: 201005757