Clinicians at participating sites
Is this trial open to recruitment 
No. The trial has met its recruitment target and no new participants can be enrolled.
Can we include patients that have been transferred in from other units?
Yes - If the primary reason for admission to the other unit was sepsis and the patient was transferred to your unit for ongoing care of sepsis-related illness.
What if patients develop sepsis during their ICU stay, but are not admitted with sepsis?
Unfortunately they are not eligible for the trial.
Are patients eligible for the trial if they have received a pneumococcal vaccine previously?
Yes, as long as the vaccination was performed before the sepsis-related illness
Prior to enrolling should we check flu vaccine status with the GP for patients admitted less than 7 days previously?
Patients are allowed to receive the flu vaccine during the trial. If the patient is eligible for VACIRiSS trial and are admitted to hospital for less than 7-days, please confirm the vaccination status with GP.
Can we enrol patients who are given corticosteroids into the trial?
Patients who have received corticosteroids are potentially eligible for the trial, provided the cumulative dose is less than 0.5mg/Kg of prednisolone or equivalent for a maximum of 14 days prior to enrolment.
For example, if a patient received 1mg/Kg of prednisolone for 7 days and then the dose was tapered over the next 7 days, as long as the average daily dose of prednisolone was less than 0.5mg/kg over the course window they are eligible. However, if the steroid dosing extended beyond 14-days, they are not eligible.
Can we recruit patients that are not local to the hospital?
Following up patients in this trial involves two hospital visits after being discharged.
Patients who are not local to the hospital might find it inconvenient to return for these visits, so this should be discussed before enrolling patients into the trial.
Can we recruit patients that are non-English speaking?
Yes. As long as they are able to understand the information provided in the patient information sheet and agree to participate in the trial.
Can we enrol patients who have persistent delirium and/or confusion?
Potentially yes, if the delirium or confusion is thought be a temporary event and the patient is likely to recover. In this scenario, assent has to be obtained either from the legal representative or from a professional consultee who is not directly involved with the trial. Patient consent has to be completed when they are clinically better or at one of the follow-up visits.
If a patient doesn’t regain capacity to consent, is the assent provided still valid?
Yes.
My patient is taking part in an observational study, can we enrol them into VACIRISS?
Yes. VACIRiSS Trial allows co-enrolment into observational studies.
My patient is taking part in another CTIMP, can we enrol them into VACIRISS?
Potentially, yes. Please contact the CI with details of the trial. If agreed, a co-enrolment agreement for both trials will be put in place.
Can nurses take informed consent?
The trial protocol allows informed consent to be taken by a research nurse, if local policy/guidelines permit this. Please confirm this with your organisation. A delegated medic must always sign off eligibility before a nurse can take consent.
Can nurses administer IMP?
Yes. The nurse administering the IMP must be blinded to the allocation of the intervention.
Can nurses prepare IMP instead of pharmacy?
Yes, if you can assign them to be unblinded for the duration of the trial. IMP must be prepared using aseptic techniques, and unblinded staff cannot be involved in any other aspect of the trial. IMP must be administered by blinded team members.
I’m an unblinded research nurse but I’d like to change roles and become blinded (or vice versa). Is this possible?
Unfortunately not. Once your status has been confirmed, it is not possible to change this for the duration of your time spent working on the trial.
What do we do if a patient enrolled into the trial had a clinical deterioration before administering IMP?
If there is a clinical deterioration (for example new fever or worsening illness) then IMP administration can be deferred until the patient’s clinical condition improves. There is no time limit for this recovery.
It is important to note that once prepared, IMP is stable only for 24 hours, so it should only be prepared when the patient is feeling better.
What do we do if a patient refuses blood sampling or it is not technically feasible?
Either situation will not be considered as a protocol deviation. Please write a file note explaining the reasons for not completing blood sampling.
How do we arrange follow up visits?
At the time of IMP administration, please ask patients how they would prefer to be contacted and if transport arrangements are needed to attend follow-up visits. Please contact the patient prior to the follow-up visit to confirm the time, place and, transport arrangements.
Can we visit patients at their usual residence to collect blood samples?
Yes, if resources at site and local policies allow for this.
Do planned hospital admissions need to be reported as SAEs?
No. Planned hospital admissions should not be reported as SAEs.