PPIE co-applicant for clinical trial
Sepsis is a life-threating condition due to a severe infection. It is a common reason that patients require ‘life-support’ in the form of help from a breathing machine, a kidney machine or powerful drugs that boost the blood pressure. Sepsis is a leading cause of death worldwide.
Antibiotics are a major part of the treatment of sepsis, but antibiotics also carry significant risks. The overuse of antibiotics is leading to the emergence of resistant superbugs, which is a major global health threat. There are also harms that individual patients can experience such as antibiotic-associated bowel inflammation (caused by a bug called Clostridium difficile), toxic effects of drugs and longer time requiring organ-support in ICU.
Striking the right balance of using antibiotics appropriately while avoiding the harms is a significant challenge. Often if a patient is unwell, antibiotics will be initiated rapidly because the risk of missing an infection is too high. However, once antibiotics are started, the exact duration of antibiotics that are needed to adequately treat an infection is unknown. International guidelines recommend 7-10 days, but there is little evidence to support this. Furthermore, studies that have tested different antibiotic durations in specific infections often do not include critically ill patients. Determining a duration of antibiotics that effectively treats the infection but is not unnecessarily prolonged, could have a big impact on antibiotic use overall.
We aim to determine whether short duration antibiotic treatment is as good as routine practice. We will carry out a trial including adult patients with sepsis who are admitted to critical care for organ support. We will randomly assign patients to receive short duration antibiotics, which will be a 5-day course, or usual care. This trial will only specify the duration of antibiotics. The choice or combination of antibiotics will be decided by the clinical team. The clinical team will know what duration the patient is receiving and so antibiotic decisions beyond the 5-day period will be up to the clinical team.
We will determine whether short course antibiotic treatment is as effective as routine practice by looking at what happened to patients while they were in hospital and how they are at 3-month and 1-year follow up.
If we can demonstrate that shorter durations of antibiotics are as effective as routine practice this would mean that we could effectively treat sepsis while reducing antibiotic overuse. This could lead to major benefits to patients and have a significant impact on clinical practice.
We are in the process of applying for funding for this project and we are looking for a member of VOICE to join the research team as a co-applicant.
This is an antibiotic stewardship trial for sepsis in critical care. Therefore someone who has survived sepsis or critical illness would be able to provide a valuable patient perspective. Alternatively someone who has had a relative who has survived sepsis/critical illness or some other connection to critical illness and can represent patient and public views, would be very welcome.
What will I be asked to do?
During the grant application phase the PPIE member will be asked to review the lay summary and give a patient perspective on the research question and design. If funded, the individual will be asked to contribute to the consent forms and patient information sheets. In addition the lay member would join the trial management group and attend the trial management group meetings to provide a patient/public perspective.
When and where?
This project is in the early stages of applying for funding. If successful in all stages of funding, the outcome would be in November 2021 and the trial would start in November 2022. The trial management group meetings would occur approximately monthly once the trial commences. I would hope that by then we would be in a position to have face-to-face meetings but its likely they would be a combination of online and in-person meetings. In-person meetings will be held at Newcastle University.
Will I get anything for taking part?
All PPIE involvement will be fully costed into the grants so time, travel and subsistence will be covered.
PPIE co-applicant for clinical trial Discussion
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