Feasibility Study of Contemporary Diagnostics for Patients With Suspected Hospital-Acquired Pneumonia. (HAP-FAST)

Feasibility Study of Contemporary Diagnostics for Patients With Suspected Hospital-Acquired Pneumonia.

Feasibility Study of the Clinical and Cost-effectiveness of Contemporary Diagnostics for Patients With Suspected Hospital-Acquired Pneumonia (HAP).

Hospital-Acquired Pneumonia (HAP) is a severe lung infection that develops while a patient is in hospital. We aim to design a trial to see if modern diagnostic investigations can safely improve outcomes for patients suspected of HAP. Currently, doctors use chest x-rays to make the diagnosis, but these are difficult to interpret and a third of patients suspected of HAP receive antibiotics inappropriately. Patients are concerned about misdiagnosis and a solution might be to replace the chest x-ray with a CT scan since these show the lungs in more detail. Once a diagnosis of HAP is made, doctors would like to identify the bacteria or viruses responsible. However, current tests are too slow to determine the initial treatment, so guidelines suggest we cover a range of possibilities with two extended spectrum antibiotics. Patients tell us they are concerned, because these antibiotics increase the risk of severe side effects and promote antibiotic resistance. The BIOFIRE® FILMARRAY® pneumonia panel (FAPP) is a new test that can identify the cause of HAP quickly. If we can determine the best way to use the FAPP, we can give antibiotics more effectively and slow the development of antimicrobial resistance. We will conduct a feasibility study to inform the design of a fully powered trial to discover whether using CT scans or the FAPP, or both together, helps improve antibiotic use and patient recovery whilst being cost effective. We will interview some participants and staff about how the trial is working so that we can improve the design. We will list the costs associated with HAP so we can design a cost effectiveness evaluation for the definitive trial. We will use patient samples to investigate immune and inflammation related processes to better understand why some people develop HAP and why some become particularly unwell.

Patients will receive a chest x-ray and their sputum sample will be analysed using the FilmArray Pneumonia Panel.

Patients will receive a chest x-ray and their sputum sample will not be analysed using the FilmArray Pneumonia Panel.

Patients will receive a CT scan and their sputum sample will be analysed using the FilmArray Pneumonia Panel.

Patients will receive a CT scan and their sputum sample will not be analysed using the FilmArray Pneumonia Panel.

The FilmArray Pneumonia Panel is used to analysis the patient's sputum sample for the cause of the hospital acquired pneumonia

Determine the feasibility of a full-scale Randomised Controlled Trial (RCT) comparing different diagnostic dynamic treatment regimens (DTRs) in adult patients suspected of HAP.

Rate of recruitment; proportion screened that meet eligibility criteria; proportion eligible that consent and where they present; proportion consented and randomised that complete study pathway as per protocol; proportion consented and randomised that withdraw from trial intervention or follow up.

Time to clinical cure, defined as the number of days from baseline when there is a combination of resolution of signs and symptoms present at enrolment and improvement or lack of progression of radiological signs.

We will evaluate the best way to record this by analysing: in-hospital mortality, survival at three timepoints.

Participants who attend 28 day visit and complete the post discharge indirect cost survey at 90 days.

Perform a costing analysis of HAP to inform the cost-effectiveness analysis for any definitive trial.

Assess human factors involved in delivery of the study and how the different diagnostic tests influence clinical decision making by conducting qualitative interviews and focus groups with healthcare workers and researchers.

Inclusion Criteria: Stage 1: ≥ 18 years Patients with suspected HAP Stage 2: The clinician intends to treat the patient for HAP or a hospital acquired respiratory tract infection (RTI). A sputum sample can be obtained Exclusion Criteria: Stage 1: Intention to palliate rather than cure Interventions cannot be completed before administration of second antibiotic dose Cannot have low-dose, non-contrast CT scan on clinical grounds Pregnancy Previous study participation (patients with second or third episodes of HAP will not be re-recruited) Stage 2: Following the CXR or CT the clinician decides not to treat with antibiotics for either HAP or a hospital acquired RTI. A sputum sample cannot be obtained