Site Restart
Sites halted recruitment into ADAPT-Sepsis due to Covid-19. Before restarting, we must ensure that we have;
- Capacity and Capability Confirmation from your R&D Office
- Confirmation that study participants’ safety has been assessed and risks exposure to COVID-19 due to hospital attendance have been mitigated by the Trust (if not included in C&C).
- Confirmation of SIV refresher training received.
- Confirmation PCT orders have been received.
- Database status amended to ‘Active-recruiting’.
Trial Restart FAQs
Why is this trial important?
The ADAPT-Sepsis Trial is the result of a National Institute of Health Research (NIHR) Health Technology Assessment (HTA) commissioned call for high quality evidence in the field of biomarker-guided antibiotic duration in sepsis to benefit patients. It responds to evidence gaps and recent research recommendations from NICE (Diagnostic Guidance (DG 18) for Sepsis 2015). Importantly, NICE recommend that UK hospitals already using PCT for antibiotic guidance in sepsis should be encouraged to engage with trials seeking to understand its clinical and cost effectiveness in the NHS – which is what ADAPT-Sepsis aims to do.
During the COVID-19 pandemic, NICE has produced additional guidance for the use of antibiotics when treating hospitalised patients with highly suspected or confirmed COVID-19 (NICE NG173). This new NICE guidance confirms that the use of biomarkers to guide antibiotic duration, such as PCT, should be in the context of a clinical research trial. The ADAPT-Sepsis trial continues to include critically ill adult patients with suspected sepsis resulting from any infectious cause, which can also include COVID-19.
Who is funding this trial?
National Institute of Health Research (NIHR) Health Technology Assessment (HTA) Commission.
How many sites will participate in ADAPT-Sepsis?
We are aiming for at least 38 sites across the UK.
Are you looking for new sites?
We are looking for new sites as we re-start the study across the UK.
When will the ADAPT Sepsis trial re-start recruitment?
The trial has now re-started 04 Aug 2020. The Warwick Clinical Trials unit are currently in contact with sites and working towards reopening those who are ready.
Does the ADAPT Sepsis trial team need to submit an amendment for the study to restart?
No, guidance from HRA (Section 3.1.4) confirms that we can reopen the trial without any amendments.
How long will the trial be open for and what is the recruitment target?
The trial opened in January 2018 and is scheduled to run until July 2024 with the aim of recruiting 2,760 patients.
What would be the per site recruitment target?
To achieve our recruitment target, we need sites to recruit approximately 4 patients per month from the time they join the trial. The target will remain the same with the recruitment period being extended to allow you to meet the target
Equipoise
We have started using PCT in routine practice since the COVID-19 outbreak, can we continue to take part in the ADAPT-Sepsis trial?
During the COVID-19 pandemic, NICE has produced additional guidance for the use of antibiotics when treating hospitalised patients with highly suspected or confirmed COVID-19 (NICE NG173). This new NICE guidance confirms that the use of biomarkers to guide antibiotic duration, such as PCT, should be in the context of a clinical research trial. The ADAPT-Sepsis trial continues to include critically ill adult patients with suspected sepsis resulting from any infectious cause, which can also include COVID-19.
You will not be able to continue routinely measuring PCT for trial patients and must be able to ensure a position of equipoise for an individual trial patient. We do not insist that you stop using PCT for other patients who are not recruited into the trial, but we do not promote its use outside of a trial in line with current NICE recommendations. We would also highlight that as part of ADAPT-Sepsis trial, every trial patient will receive individualised biomarker-guided protocol advice about antibiotic use every day during their sepsis episode.
Has the Personal Consultee consent process changed because of the COVID-19 pandemic?
Yes. Due to the hospital visiting restrictions in place during the COVID-19 pandemic, it is now less likely that a personal consultee will be physically available for consultation. Site teams may contact a personal consultee over the telephone and obtain verbal confirmation that they do not know of any objection to research participation expressed by the participant. This must be clearly documented in the patient’s notes and a Personal Consultee information sheet and consent form sent out in the post which should be signed and returned to the local site research team.
About Personal consultee consent – where you feel the personal consultee may not return the written consent forms:
Ours is a pragmatic solution and we are continuing to advise sites that if they are concerned about obtaining personal consultee declaration, they should get professional consultee declaration in the first instance, they are then able to contact the families/friends via telephone and document this in the patient notes but there would be no concerns if the completed form wasn’t returned as the initial professional consultee decision is sufficient.
Is there any specific study guidance on infection control and PPE requirements?
The ADAPT-Sepsis trial supports adopting your locally agreed infection control guidance and practice for treating hospitalised patients with suspected sepsis.
Can patients with highly suspected or proven COVID-19 take part in the ADAPT-Sepsis trial?
Yes, the SARS-CoV-2 virus can be a cause of severe pneumonia and sepsis requiring critical care. If antibiotics for severe pneumonia and sepsis have been commenced, and all other eligibility criteria are confirmed, then the patient can be offered participation in the study if the patient’s treating clinical team agree.
Can we co-enrol with Urgent Public Health trials?
We are currently ensuring co-enrolment with UPH trials, please see the co-enrolment tab for an up-to-date list.