INHALE Work Package 2
Research type
Research Study
Full title
INHALE: Potential of Molecular Diagnostics for Hospital-Acquired and Ventilator-Associated Pneumonia in UK Critical Care. Work Package 2: Epidemiological Sub-study
IRAS ID
203117
Contact name
Vanya Gant
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2016/07/81 , UCL Data Protection Registration Number
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Severely-ill hospital patients often develop pneumonia. To treat effectively, secretions from the lungs and respiratory tract are sent to the hospital laboratory to identify bacteria and see which antibiotics kill them. Testing takes 2 days or more, during which a “broad-spectrum antibiotic”, capable of killing many different types of bacteria is given. This isn’t ideal. Some patients with pneumonia symptoms don’t have bacterial infection. Some have highly resistant bacteria, not killed even by broad-spectrum antibiotics; this doubles the risk of death in severe pneumonia. Broad-spectrum antibiotics promote undesirable side effects including diarrhoea, and can increase resistance, making future infections harder to treat. Many pneumonia patients have very susceptible bacteria and are ‘over-treated’ until the lab result becomes available.
New ‘molecular diagnostic’ tests, which work by identifying bacteria directly from their genetic material present in a clinical sample, claim to identify bacteria and their resistances within 1-4 hours. This would allow treatments to be optimised earlier, benefitting individual patients and allowing the most potent antibiotics to be reserved for those who really need them. Three molecular diagnostic systems are available, but we don’t know which is best, how results compare with current methods, whether they find all the important types of resistant bacteria or whether they represent value for money.
In this observational study, we will test secretion samples from 200 patients with suspected pneumonia in the intensive care units of four hospitals selected to represent a cross-section of healthcare in the UK. All samples will be processed in the hospital laboratory and, in addition, by the three molecular diagnostic systems to see how accurate they are and how easy they are to use. We will also collect clinical information from patient notes, and deliver a short patient telephone questionnaire. Results will be used to inform design of a clinical trial.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
16/LO/1618
Date of REC Opinion
27 Sep 2016
REC opinion
Favourable Opinion