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Eligibility
Local study conflicts
Inclusion Criteria:
- Female, aged 18 years or above
- Participant is willing and able to give informed consent for participation in the trial.
- Presenting with acute pyelonephritis symptoms for which the responsible clinician considers antibiotic treatment is either indicated or has been started within the previous 72 hours.
- All three of:
- Fever, evidenced by either a measured temperature of ≥38.0°C at any time since onset of symptoms (including by the patient prior to presentation) OR, if the patient has taken antipyretics or antibiotics in the last 24 hours, reported fever, chills or rigors since the onset of symptoms
- Loin/flank pain or costovertebral angle tenderness
- ≥ 1 symptom of acute UTI (frequency, dysuria, urgency, nocturia, change in urine smell or appearance (e.g. cloudy or bloody urine), suprapubic pain).
- Patient is willing to allow their General Practitioner (GP) to be notified of participation in the trial.
- (For the Qualitative Sub-study only: English speaking)
Exclusion Criteria:
- Previous participation in the DURATION UTI Trial.
- Indwelling catheter.
- Inclusion in the trial is inappropriate in the judgement of the responsible clinician.
- Known anatomical abnormality of the urinary tract.
- Neurogenic bladder.
- Known pregnancy (pregnancy test not required for participation-see section 8.4 for further details).
- Unable to comply with study procedures.
- All antibiotic agents available to the participant in the trial are precluded in the view of the
responsible clinician, for example by:
- Patient factors (such as allergy, degree of renal impairment).
- Antibiotic susceptibility results (e.g. known carrier of antibiotic resistant organisms or resistance profile of the current infection, if known at randomisation).
If the patient is eligible:
- Gain verbal agreement in principle before proceeding. Explain:
- Taking part in research is likely to improve the quality of their care
- Risks are carefully controlled - research is safe
- Explain the uncertainty that exists with respect to treatment of their condition
- If they change their mind they can withdraw their participation at any point
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Step-by-Step Guide to Recruitment:
In the working hours of the research team:
- Monday-Tuesday 07:30 – 20:00
Wednesday 07:30- 18:00
- Contact the EMROx research team on:
Mobile 0776818242
Tel 01865 222003
Bleep 6680
Out of hours and weekends:
Gather documentation
- Where to collect documentation
Gaining formal consent
- Steps to consent and document it
- If capacity/no capacity are different; get the framework from comited in emerg-sci.web.app
- etc
Randomisation procedure
- Randomisation steps
Carrying out the intervention:
- [steps undertaken]
Disposition and follow-up:
If admitted:
If discharged:
Links for further information:
Link to trial site