Trial Outcomes & Findings for A Pilot Comparison of Short-course Nitrofurantoin in Females With Uncomplicated Bacterial Cystitis in the Emergency Department (NCT NCT01749605)

Last Updated: 2017-05-31

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

35 participants

Primary outcome timeframe

7 days

Results posted on

2017-05-31

Participant Flow

Participant milestones

Participant milestones
Measure	Nitrofurantoin 100 mg Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days	Ciprofloxacin 250 mg ciprofloxacin 250 mg BID x 3 days
Overall Study STARTED	18	17
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nitrofurantoin 100 mg n=18 Participants Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days	Ciprofloxacin 250 mg n=17 Participants ciprofloxacin 250 mg BID x 3 days	Total n=35 Participants Total of all reporting groups
Age, Continuous	24.4 years n=93 Participants	25.1 years n=4 Participants	24.75 years n=27 Participants
Sex: Female, Male Female	18 Participants n=93 Participants	17 Participants n=4 Participants	35 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants n=93 Participants	17 Participants n=4 Participants	35 Participants n=27 Participants
Region of Enrollment United States	18 participants n=93 Participants	17 participants n=4 Participants	35 participants n=27 Participants

PRIMARY outcome

Timeframe: 7 days

Outcome measures

Outcome measures
Measure	Nitrofurantoin 100 mg n=14 Participants Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days	Ciprofloxacin 250 mg n=14 Participants ciprofloxacin 250 mg BID x 3 days
Number of Participants With Clinical Cure at Day 7	13 participants	12 participants

Adverse Events

Nitrofurantoin 100 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ciprofloxacin 250 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nitrofurantoin 100 mg n=18 participants at risk Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days	Ciprofloxacin 250 mg n=17 participants at risk ciprofloxacin 250 mg BID x 3 days
Skin and subcutaneous tissue disorders Rash	5.6% 1/18 • Number of events 1	0.00% 0/17
Gastrointestinal disorders Nausea	0.00% 0/18	5.9% 1/17 • Number of events 1

Additional Information

Brett Faine, PI

University of Iowa

Phone: 319-310-8067

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place