INtravesical Antimicrobial Agents Versus STANDard Oral Antibiotics for the Treatment of Acute Urinary Tract Infection in Women With Recurrent Urinary Tract Infection (INSTANT Study)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Change in microbiologic effect of a chronic acute Urinary Tract Infection
研究概览
简要总结
Women have problems with oral antibiotics, including vagina and bowel infections. Also, bacteria causing urinary infections are becoming more resistant to oral antibiotis. Placement of antibiotic directly into the bladder does not cause these problems and are at doses that are may be able to stop bacteria from being resistant to antibiotics.
详细描述
Each participant once enrolled returns with an active Urinary Tract Infection (UTI), confirmed by urine void. Participants will complete an UTI questionnaire, and if consistent with a simple non-febrile UTI will be randomized to one of two arms: oral nitrofurantoin treatment for 7 days, or intravesical gentamicin instillation once a day for three days. Patients will be followed for symptom relief with a repeat voided urine in 7 to 10 days, and with a repeated questionnaire for symptom relief.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ability to understand study procedures and to comply with them for the entire length of the study.
排除标准
- •Patients who report that they are pregnant.
- •Patients with a positive urine pregnancy test
- •Patients with a history of renal transplantation.
- •Patients with bladder augmentation procedures using bowel.
- •Patients with poorly controlled Type II diabetes, Hgb A1C >6.5%
- •Patients with spinal cord injury, ASIA Impairment Scale of C or higher.
- •Patients with pelvic surgery within 6 months.
- •Patients with urologic procedure within 6 months.
- •Patients with a history of reconstructive urologic surgery, such as reflux, congenital abnormality.
- •Immunocompromised patients being treated for malignancy or a history of actively treated malignancy within 5 years.
- •Patients with active systemic autoimmune disease.
- •Patients on systemic immunosuppression.
- •Use of antibiotic prophylaxis within 6 months
- •Use of antibiotics within 10 days of active infection
- •Allergy/sensitivity to gentamicin or nitrofurantoin.
- •Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- •Inability or unwillingness of individual to give written informed consent.
研究组 & 干预措施
Oral Nitrofurantoin
Participants will randomized to oral nitrofurantoin
干预措施: Nitrofurantoin (Drug)
Intravesical Gentamicin
Participants will be randomized to intravesical gentamicin
干预措施: Gentamicin (Drug)
结局指标
主要结局
Change in microbiologic effect of a chronic acute Urinary Tract Infection
时间窗: baseline, 7-10 days
Microbiological culture growth of susceptible organisms obtained on day 0, compared with voided urine culture as no growth in 24-48 hours obtained at 7-10 days
Change in symptomatic relief of a chronic acute Urinary Tract Infection
时间窗: baseline, 7-10 days
Completion of a Symptom Urinary Tract Questionnaire. Tracking the symptoms in the past 24 hours. Indicating how severe and how bothersome they were. Severe ranging from 0 (Did not have) to 3 (Severe). Bothersome ranging from 0 (Not at all) to 3 (A lot)
次要结局
- To establish the clinical FTE needs for providing urgent intravesical treatments(baseline, through stufy completion, an average of one year)
研究者
Deborah J. Lightner
Principal Investigator
Mayo Clinic