31 March 2020
MicroBioSensor - New device for treatment of peritonitis undergoes clinical trials
A trial of a medical device which could improve the diagnosis and treatment of peritonitis for patients undergoing peritoneal dialysis, has started in ten major hospitals across the UK.
The QuickCheck device has been developed by MicroBioSensor over the past five years in collaboration with the Peritoneal Dialysis Unit at Manchester Royal Infirmary to act as an early-warning system for peritonitis, and to provide guidance on the correct choice of antibiotic to treat the infection.
The trial is being led by Professor Martin Wilkie, consultant nephrologist at Sheffield Teaching Hospitals NHS Foundation Trust, and will assess the efficacy of the device in peritoneal dialysis patients who both have and have not been infected with peritonitis. The trial is likely to last between four and five months. On successful completion of the study MicroBioSensor will submit a CE mark application for QuickCheck, which will allow them to launch the product in the UK and Europe.
Professor Martin Wilkie said: “The team here at Sheffield are really pleased to be involved in this clinical study. Trying to move testing nearer to the patient is key to improving patient care.”
Peritonitis is a life-threatening infection and is one of the most common complications for patients undergoing peritoneal dialysis. One in 20 peritonitis episodes results in the death of the patient, and patients have up to a 50% chance of contracting peritonitis for every year that they undergo peritoneal dialysis.
Peritonitis in peritoneal dialysis patients is currently diagnosed using the ‘cloudy effluent test’, where patients obtain a sample of their effluent and judge whether it is cloudy by attempting to read newsprint through it. The diagnosis is confirmed by a test carried out in hospital to count the leukocytes present in the dialysis fluid. If leukocyte levels have reached 100,000 cells per ml or more, peritonitis is confirmed. This lengthy process means that the peritonitis infection has often already taken hold by the time of diagnosis, which can make effective treatment more difficult.
The QuickCheck device uses MicroBioSensor technology to detect high leukocyte or microbial cell levels, which indicate a patient is developing peritonitis, and alerts healthcare staff via a colour change. These results are available immediately at the end of an overnight dialysis session.
QuickCheck is therefore able to flag an emerging infection at an early stage and confirm infective peritonitis without further delay: something no other product on the market can do. In addition, it provides vancomycin sensitivity, the front-line antibiotic most commonly prescribed for infective peritonitis, providing guidance on the most effective antibiotic to treat the infection. This information is available to doctors as soon as the patient arrives at hospital for treatment.
It typically takes two days for hospitals to obtain antibiotic susceptibility information for peritonitis patients, thus delaying their access to the most effective treatment.
Anand Vardhan, consultant nephrologist, Manchester, said: “Currently results arrive about 48-hours too late to have a meaningful impact on patient treatment.”
The QuickCheck device provides this information at diagnosis, so clinicians can prescribe the most effective antibiotic straightaway.
This also reduces the incidence of antibiotic resistance, as the over-use of partially ineffective antibiotics increases the development of resistance.