Single Dose Monurol for Treatment of Acute Cystitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of Participants Who Were Cured
研究概览
简要总结
Urinary tract infecton (UTI) is a very common problem in young healthy women, afflicting approximately one-half of women by their late 20's. One of the most common antibiotics used to treat UTIs is Trimethoprim-Sulfamethoxazole (TMP-SMX), usually for total of three days. However, concerns about increased antibiotic resistance have led to increased interest in studying other antibiotics for UTI.
An alternative antibiotic which is also FDA approved for the treatment of UTIs is fosfomycin (Monurol). The effectiveness of fosfomycin in curing UTIs when given as a single dose is not well studied. The purpose of this research study is to determine what the cure rates are with a single dose of fosfomycin versus the more standard 3-day course of TMP-SMX.
详细描述
Procedures subjects will undergo once they have read and signed the consent are:
Questions about their medical and sexual history and current symptoms of UTI. They will be asked to provide a urine and peri-urethral sample and then are randomly assigned to one of the two treatment groups.They will be given a sheet to record symptoms at home. They will be asked to return to the clinic in 5-8 and 28-30 days after completing antibiotic therapy.Follow-up questions will be asked and urine and peri-urethral will be self collected at each visit.
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
- None
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
- •Non pregnant women in good health with symptoms of acute cystitis for less than 7 days
排除标准
- •Pregnant, lactating, or not regularly contracepting
- •History of chronic conditions such as diabetes
- •Known anatomic abnormalities of the urinary tract
- •Use of prophylactic antibiotics
- •History of allergy or intolerance to any of the study drugs
- •Recent (> 2 weeks)exposure to oral or parenteral antimicrobial
- •History of UTI in previous 1 month
研究组 & 干预措施
TMP/SMX
Sulfamethoxazole-Trimethoprim 800-160 MG Oral Tab; 800mg/160mg BID x 3 days
干预措施: TMP/SMX (Drug)
Fosfomycin
3g sachet single dose
干预措施: Fosfomycin (Drug)
结局指标
主要结局
Number of Participants Who Were Cured
时间窗: 28-30 days post therapy
Cure as defined by no further treatment for subsequent or unresolved symptoms, by modified ITT approach.
次要结局
未报告次要终点
研究者
Ann Stapleton
Professor, Medicine, Infectious Diseases
University of Washington