Frequently asked questions

  

If symptomatic UTI is present at baseline, how long is it before the patient can be randomised?  Is another MSU required to confirm no current infection before randomisation?

The patient can be randomised once they are asymptomatic. A baseline urine specimen taken when the patient has become asymptomatic should be sent to the central laboratory. There is no trial requirement to re-check that bacteriuria has cleared following treatment urine at the local laboratory.

 

If local lab results are used at baseline, how recent should these be?

Within 2 months.  Serum levels of creatinine and LFTs checked at local lab. Baseline urine sample and swab to central lab.   Urine sample to local lab if required, no swab sent to local lab. End of study urine and blood sample sent to central lab.

 

Is there any advice for the GP on which antibiotic to use or not to use in the GP letter?

GP letter states whether participant has been randomised to prophylaxis or no prophylaxis – if randomised to prophylaxis please add name of drug before sending the letter.  Additional GP information sheet sent with the letter gives further advice to the GP about treatment of UTI and changing of drug used for prophylaxis.

 

If the participant has to contact GP out of hours or at weekend, how will out of hours doctor know about the study?

We have provided a patient card for the participant to carry giving details of the study.  This will has been approved by REC.

 

Should the NuTH NHS FT AnTIC Trial prescription be used for other sites?

There is no MHRA or Trial requirement to use a trial-specific prescription and it is up to local operating procedures whether a trial-specific, a standard internal hospital, or a FP10 is used to prescribe trial drugs. NuTH NHS FT chose to use a trial-specific prescription in line with local SOPs. Logistically it is best to initially issue a 3-month supply of study drug following randomisation from the study site (hospital) and then determine whether further prescription will be issued by the study site or GP at the time of 1 month review.

 

Perineal or Perianal Swabs?

After discussing this issue, we chose perianal after advice from our patient representative as she felt people would know what was meant.  From bacteria gathering point of view the nearer the anus the better.

 

Frequency of catheterisation?

Those who catheterise at least once every 24 hours can be included in the study. 

 

Is a local lab urine result always required?

Yes and if a result is available from within the last two months then this can be used.  A baseline local urine within the previous 2 months even if asymptomatic is required as patients may have bacteriuria that may be used to choose the prophylaxis agent.  Results sent from GP can be used as well.

The sample is not an entry criterion and, if there are not any, leave the boxes  on the CRF blank, but it would be unusual not to have had any urine specimens sent in this patient group. You can also send one at the time of the randomisation visit - half of the baseline specimen, and fill in the result later.

It is helpful to tell staff who identify eligible patients to get a urine specimen and creatinine/LFTs proactively before they are seen by you.