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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01749605
Recruitment Status : Completed
First Posted : December 13, 2012
Results First Posted : April 27, 2017
Last Update Posted : May 31, 2017
Information provided by (Responsible Party):
Brett A Faine, University of Iowa

Brief Summary:
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 or disease Intervention/treatment Phase
Uncomplicated Bacterial Cystitis Drug: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days Drug: ciprofloxacin 250 mg BID x 3 days Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number of Participants With Clinical Cure at Day 7 [ Time Frame: 7 days ]
    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)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01749605

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

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Responsible Party: Brett A Faine, Clinical Pharmacy Specialist, University of Iowa Identifier: NCT01749605    
Other Study ID Numbers: 201005757
First Posted: December 13, 2012    Key Record Dates
Results First Posted: April 27, 2017
Last Update Posted: May 31, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Urinary Bladder Diseases
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents