Eligibility

Local study conflicts

None

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:
1. 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
2. Loin/flank pain or costovertebral angle tenderness
3. ≥ 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

Step-by-Step Guide to Recruitment:

In the working hours of the research team:

Monday-Friday 07:30 – 18:30

Contact the EMROx research team on:
Mobile 0776818242
Tel 01865 222003
Bleep 6680

Out of hours and weekends:

Estimated time to enrol:

30-40 minutes

Eligibility Confirmation

Delegated Doctor confirms eligibility.
Note: A copy of the delegation log can be found in this link: DURATION UTI study recruitment pack

Gather documentation and pack

The DURATION-UTI study documentation is electronic based, with the option to use paper documents.
The patient information sheet can be accessed at: DURATION UTI study recruitment pack (Trust login required)
Location of Sample Kits

ED Research laboratory ( next to ENP room) door is coded; message ED Research via whatapps for the code.
AAU store room

Main urine sample kit for patient

Rectal sample sub study for patient

Screening, Eligibility Confirmation Consent & Randomisation can be carried out by using either Electronic or paper clr

Consent the patient for:

The main study investigating duration of antibiotic therapy on effectiveness
Optional rectal swab sub-study
Optional Qualitative Process Evaluation SUB-STUDY English speaking
Patient information sheets and informed consent forms all in the DURATION UTI study recruitment pack (links in the next section)

Click to Select consent record method: Electronic or paper

Screening, Eligibility Confirmation Consent & Randomisation: Paper

You can also use paper for eligibility confirmation, patient information sheet (PIS) and informed consent form (ICF). These documents are available via this link DURATION UTI study recruitment pack Note: Only a delegated doctor can confirm eligibility. A copy of the delegation log can be accessed via the same link

Only clinicians on the study delegation log may confirm eligibility and/or recruit patients to the study
Confirm Eligibility by completing the paper Eligibility Form.
Provide the patient with a patient information sheet and ask them to read it
ask the patient to sign the consent form
Assign a Study ID e.g. DU-JRH-001. This can be found in the DURATION UTI recruitment pack located in EMROx Laboratory L1 ED code access only. Ask the EMROX team for code via Whataspp
Log on to Link to DURATION UTI edatabase REDCap (ox.ac.uk). Log In access is issued individually
Add patient by clicking on add/edit records. Click green tab Add new record
Click on Consent Form Participant. Ask the patient to go through each consent condition and if the agree type their initials. Patient signs at the end of the page. Then click Save and Exit Form
Click on Record Status Dashboard and click on the record you recently filled up
Click on Choose action for record dropdown tab. Choose rename record with the next available DURATION UTI ID : DU-JRH- 001

Image of a duration pack with unique reference number

Click on Consent Form Staff and complete. Save & Go To the Next Form
Complete the Contact Details. Save and Go to Next Form
Complete the Eligibility Form. Save & Go to Next Form. Eligibility confirmation must be performed by the study delegated doctor. Copy of delegation log can be accessed via RECRUITMENT PACK
Click Auto randomise
Click Randomisation result
Inform the clinician in charge of patient care of the allocated duration of antibiotic treatment. Ask them to prescribe Betalactam according to the randomised outcome. If patient is allergic discuss alternative drug with Principal Investigator.

Carrying out the intervention:

Post Randomisation Instructions

The research or clinical team provide the patient with the DURATION UTI Main Urine Sample kit, and the Rectal Sample kit if patient signed up to the rectal sub-study.
Copy the DURATION UTI ID from the Main Urine Sample Kit unto the Rectal Sample kit

Prescribing:

Inform the clinician in charge of patient care of the allocated duration of antibiotic treatment. Ask them to prescribe Betalactam according to the randomised outcome.
If patient is allergic discuss alternative drug with Principal Investigator

Samples:

If the patient has not started an antibiotic yet
1. Collect urine sample. Check if a blood culture was sent off. If yes, immediately inform microlab of the samples. See instructions below
2. Take the Baseline urine pot kit - unlabelled (boric acid)
3. Pour half of the urine sample into the boric acid pot. Label it using the label in the kit. Using the prepaid self-addressed envelope UN3372 Category B send the urine to Wales Trial Lab
4. Send the remainder of the urine to OUH lab for MC&S
5. Provide patient with Urine collection pack
6. Optional Rectal Swab - if consented provide patient with rectal sample kit
If the patient is already on an antibiotic
1. Check if urine and or blood culture sample were sent. If yes, immediately inform microlab of the samples. See instructions below
2. Provide patient with Urine collection pack
3. Optional Rectal Swab:
  - if consented, provide patient with rectal sample kit. Patient to collect sample at home.
  - if patient does provide the sample during the time they are in the ED, then label it & send the sample to micro lab L4
4. Instruct the patient how to use the urine and rectal (if applicable) kits
In both cases
1. Immediately inform the micro laboratory via email @Parker, Ashley (RTH) OUH, @Leach, Laura (RTH) OUH, and @Oakley, Sarah (RTH) OUH that a urine and or blood culture had been sent off to the recruit. Provide them with the patient name, MRN, sample patient name, sample collection date, and patient study ID.
2. Complete the required details on the micro-isolate collection pack.
3. Bring the micro-isolate collection pack for each sample (1 for UC and 1 for BC) with the sample labels.to level 7 MicroLab.
4. Address the pack to all three persons, Ashley Parker, Laura Leach, and Sarah Oakley so one of them can pick it up if the others are not around

Documentation

Document in the EPR that patient was confirmed to be eligible to the DURATION UTI study; that the study was discussed with the patient and patient has signed the e-Consent; and whether they have consented to the substudies.
Patient was allocated to : write the duration and who prescribed the medication.

documents

Signed paper ICF and eligibility form put it in the EMROx post box

Disposition and follow-up:

If admitted:

Take the trial drug as per randomisation duration.
Patient to complete the diary on daily basis. Take the trial drug as per randomisation duration.
Patient to send urine sample 2 days after Abx completion. Instructions is provided in the Urine sample kit
If patient signed for rectal sub study. Patient to collect and send rectal swab on or a day after enrolment. Instruction provided in the Rectal Sample Kit.

>If discharged:

Provide these instructions for the patient:
Daily diary online:
1. For those who are not able to complete online research staff can call the recruit and complete the diary
2. If patient find the diary too onerous, patient may complete it on a daily basis whilst having symptoms. Once symptom free may complete diary weekly
Participant to post urine samples 2 days after Abx course completion
Additionally, to post a urine sample if the participant contacts a healthcare professional, including a pharmacist, because they are experiencing new UTI symptoms up to & including day 42 (6 weeks) post randomisation date.
If patient is not any better after the antibiotic course, to contact GP or 111 for advise or 999for emergency.

Links for further information:

Link to trial site