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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on September 18, 2014