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

NCT ID: NCT01749605

Last Updated: 2017-05-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uncomplicated Bacterial Cystitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

nitrofurantoin 100 mg

Group Type ACTIVE_COMPARATOR

Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days

Intervention Type DRUG

Ciprofloxacin 250 mg

Group Type ACTIVE_COMPARATOR

ciprofloxacin 250 mg BID x 3 days

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days

Intervention Type DRUG

ciprofloxacin 250 mg BID x 3 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Iowa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Brett A Faine

Clinical Pharmacy Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201005757

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.