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

Information source: University of Iowa
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Uncomplicated Bacterial Cystitis

Intervention: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days (Drug); ciprofloxacin 250 mg BID x 3 days (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Iowa

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.

Clinical Details

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

Primary outcome: clinical cure at 7 days

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

Locations and Contacts

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States
Additional Information

Starting date: October 2010
Last updated: December 12, 2012

Page last updated: August 23, 2015

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