Uncomplicated Bacterial Cystitis Clinical Trial
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.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | January 2012 |
| Est. primary completion date | January 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
| Lead Sponsor | Collaborator |
|---|---|
| University of Iowa |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | clinical cure at 7 days | 7-day questionnaires included a table to measure the severity of the symptoms and their impact on daily life. Using this table, the investigators calculated a severity score (left hand column) and a bothersome score (right hand column), with a maximum score of 21 | 7 days | No |