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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brett A Faine, University of Iowa
ClinicalTrials.gov Identifier:
NCT01749605
First received: December 11, 2012
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Uncomplicated Bacterial Cystitis
Drug: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
Drug: ciprofloxacin 250 mg BID x 3 days
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • clinical cure at 7 days [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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


Enrollment: 36
Study Start Date: October 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749605

Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
  More Information

No publications provided

Responsible Party: Brett A Faine, Clinical Pharmacy Specialist, University of Iowa
ClinicalTrials.gov Identifier: NCT01749605     History of Changes
Other Study ID Numbers: 201005757
Study First Received: December 11, 2012
Last Updated: December 12, 2012
Health Authority: United States: University of Iowa Institutional Review Boards

Additional relevant MeSH terms:
Cystitis
Urinary Bladder Diseases
Urologic Diseases
Ciprofloxacin
Nitrofurantoin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on April 23, 2014