Back to resultsA Pilot Comparison of Short-course Nitrofurantoin in Females With Uncomplicated Bacterial Cystitis in the Emergency Department
Primary Purpose
Uncomplicated Bacterial Cystitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
ciprofloxacin 250 mg BID x 3 days
Sponsored by
About this trial
This is an interventional treatment trial for Uncomplicated Bacterial Cystitis
Eligibility 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
Sites / Locations
- University of Iowa Hospitals and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
nitrofurantoin 100 mg
Ciprofloxacin 250 mg
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01749605
Brief Title
A Pilot Comparison of Short-course Nitrofurantoin in Females With Uncomplicated Bacterial Cystitis in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Bacterial Cystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nitrofurantoin 100 mg
Arm Type
Active Comparator
Arm Title
Ciprofloxacin 250 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
Intervention Type
Drug
Intervention Name(s)
ciprofloxacin 250 mg BID x 3 days
Primary Outcome Measure Information:
Title
Number of Participants With Clinical Cure at Day 7
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Comparison of Short-course Nitrofurantoin in Females With Uncomplicated Bacterial Cystitis in the Emergency Department
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