ISRCTN18390724
Active, not recruiting
Phase 4
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.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Oxford
- Enrollment
- 2248
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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