ISRCTN18390724进行中（未招募）4 期
Impact of duration of antibiotic therapy on effectiveness, safety and selection of antibiotic resistance in adult women with urinary tract infections (UTI): a randomised controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,248
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Female, aged 18 years or above
- •2. Participant is willing and able to give informed consent for participation in the trial.
- •3. Urine sample for culture has been/can be obtained prior to starting antibiotics
- •4. For pyelonephritis sub trial (primary and secondary care):
- •4.1. Presenting with acute pyelonephritis symptoms for which the responsible clinician considers antibiotic treatment is either indicated or for whom an antibiotic has already been started within the previous 48 hours.
- •4.2. Temperature of >38.0oC measured at presentation AND loin/flank pain or costovertebral angle tenderness AND =1 symptom of acute UTI (frequency, dysuria, urgency, nocturia, change in urine smell or appearance (e.g. cloudy or bloody urine), suprapubic pain).
- •4.3. If recruited in secondary care, willing to allow their General Practitioner, to be notified of participation in the trial
- •5. For the cystitis sub trial (primary care only):
- •5.1. Presenting with acute cystitis symptoms for which the responsible clinician consider antibiotic treatment is indicated
- •5.2. =two of the following symptoms of acute UTI (frequency, dysuria, urgency, nocturia, change in urine smell or appearance (e.g. cloudy or bloody urine), suprapubic pain).
- •6. English speaking
排除标准
- •1. Antibiotics for the prevention or treatment of UTI within the previous month (n.b. Pyelonephritis patients that have started antibiotics within 48 hours are included).
- •2. Previous participation in the DURATION UTI Trial
- •3. Indwelling catheter
- •4. Inclusion in the trial is inappropriate in the judgement of the responsible clinician
- •5. Known anatomical abnormality of the urinary tract
- •6. Neurogenic bladder
- •7. Known pregnancy (pregnancy test not required for participation)
- •8. Unable to comply with study procedures
- •9. All antibiotic agents available to the participant in the trial are precluded in the view of the responsible clinician for example by:
- •9.1. patient factors (such as allergy, degree of renal impairment)
- •9.2. antibiotic susceptibility results (e.g. known carrier of antibiotic resistant organisms or resistance profile of the current infection if known at randomisation).
研究者
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