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OpenTrials
Completed

NCT Number: NCT01749605

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

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.

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Key information

Conditions

Uncomplicated Bacterial Cystitis

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days

Drug

ciprofloxacin 250 mg BID x 3 days

Drug

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 13, 2012
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.