RapDiBS (Rapid Diagnosis of Blood Stream Infection) Version 1.0
Research type
Research Study
Full title
Impact of Accelerate Pheno System™ for rapid identification and antibiotic susceptibility testing on time to definitive antibiotic therapy in the management of gram-negative blood stream infection.
IRAS ID
259507
Contact name
Susan Hopkins
Contact email
Clinicaltrials.gov Identifier
Z6364106/2019/10/108 , UCL data protection number
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Gram-negative bacteria are a predominant cause of bloodstream infection (BSI) associated with significant morbidity and mortality. Treatment of gram-negative BSI is becoming more difficult due to increasing rates of antibiotic resistance.
In patients with a suspected BSI, a sample of blood is taken and empiric (best guess) antibiotic treatment is started which is adjusted to targeted treatment when microbiology results become available. For the current diagnosis of BSI, the blood sample is inoculated into a blood culture bottle and incubated in a blood culture system until bacteria are detected. It can then take a further 24-48 hours to identify the bacteria and test which antibiotics are effective. During this time the patient may be receiving inappropriate empiric antibiotic therapy (either ineffective against the infecting bacteria or inappropriately broad-spectrum). In addition, if there is a multi-drug resistant bacteria present, the patient may have inappropriate infection prevention and control precautions in place.
The aim of this study is to evaluate an automated system for the rapid diagnosis of BSI. The Accelerate Pheno system (AXDX) can identify bacteria from positive blood cultures within two hours and test which antibiotics are effective against these bacteria within seven hours. AXDX has the potential to enable earlier targeting of antibiotic therapy, in addition to potentially improving patient outcomes.
We will undertake a randomised controlled trial to investigate whether AXDX can reduce the time to definitive antibiotic therapy in the management of gram-negative BSI, compared with current standard of care. This research has potential to positively impact on patient safety and the quality of healthcare by improving the use of antibiotics and treatment of infections, in addition to reducing the risk of adverse effects including antibiotic side effects, antibiotic resistance and Clostridium difficile infection.
REC name
London - South East Research Ethics Committee
REC reference
20/LO/0328
Date of REC Opinion
24 Mar 2020
REC opinion
Favourable Opinion