NCT01749605已完成4 期
A Pilot Comparison of Short-course Nitrofurantoin in Females With Uncomplicated Bacterial Cystitis in the Emergency Department
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinical Cure at Day 7
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pre-menopausal females
- •ages 18-45 years old
- •symptoms of a UTI (dysuria, frequency, urgency)
排除标准
- •Onset of symptoms >7 days prior to the ED visit
- •Non-English speaking
- •Symptoms of pyelonephritis
- •Indications of sepsis
- •Immunocompromised
- •Currently using prophylactic antimicrobials
- •Medications that could interfere with study drug
- •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
研究组 & 干预措施
nitrofurantoin 100 mg
Active Comparator
干预措施: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days (Drug)
Ciprofloxacin 250 mg
Active Comparator
干预措施: ciprofloxacin 250 mg BID x 3 days (Drug)
结局指标
主要结局
Number of Participants With Clinical Cure at Day 7
时间窗: 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)
次要结局
未报告次要终点
研究者
Brett A Faine
Clinical Pharmacy Specialist
University of Iowa
研究点 (1)
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