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Completed

NCT Number: NCT05483309

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

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.

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Key information

Conditions

Hospital-acquired Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool University Hospitals NHS Foundation Trust, Liverpool, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Stage 1:

  • Age ≥ 18 years
  • Suspected HAP*

For the purposes of this study, HAP is defined as per the BTS and FDA definitions i.e. pneumonia which develops 48 hours after an admission to hospital for an alternative diagnosis; or a new presentation to hospital with pneumonia in a patient who has been discharged from an overnight stay in hospital within the last 10 days.

Stage 2:

  • The clinician intends to treat the patient for HAP or a hospital acquired respiratory tract infection (RTI).
  • A sputum sample has been obtained before 2nd dose of antibiotic.

Exclusion criteria

Stage 1:

  • Already received a chest X-ray to confirm suspected HAP diagnosis
  • Diagnosis or suspected diagnosis of ventilator acquired pneumonia
  • Intention to palliate rather than cure
  • Interventions cannot be completed before administration of second antibiotic dose*
  • Cannot be randomised to low-dose, non-contrast CT scan on clinical grounds e.g. strong suspicion of PE**
  • Pregnancy***
  • Previous study participation (patients with second of third episodes of HAP will not be re-recruited)

In the circumstance where a patient is diagnosed with HAP whist receiving antibiotics for a non-respiratory infection e.g. cellulitis or UTI, if the HAP diagnosis leads to a change in the antibiotic prescription to cover the HAP then that patient will be eligible for recruitment. However, if the diagnosis of HAP does not result in a change in antibiotic then the patient is not eligible.

A non-contrast, low-dose thoracic CT scan is an inappropriate test for a PE and if that is high in the differential diagnosis then tick yes here.

A urine pregnancy test is required as part of routine care prior to a chest X-ray or CT scan. If the test reveals the patient is pregnant, they will not be eligible for the study as they will be unable to receive a CT scan as part of this study. Pregnancy tests are not required at future time points.

Stage 2:

  • Following the CXR or CT the clinician decides not to treat with antibiotics for either HAP or a hospital acquired RTI.

Treatment and study plan

CT Scan

Diagnostic Test

Patients receive a CT scan

FilmArray Pneumonia Panel

Diagnostic Test

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

Primary outcomes

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

    Time frame: Screening and randomisation (1 year); follow up (3 months); end of study analysis (9 months).

    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.

Secondary outcomes

  1. Estimate population statistics for each DTR - Time to clinical cure

    Time frame: Day 90

    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.

  2. Estimate population statistics for each DTR - Antibiotic usage

    Time frame: Day 90

    Antibiotic usage for the HAP episode

  3. Estimate population statistics for each DTR - Change to Quality of Life

    Time frame: Baseline, day 10, 28 and 90

    Change of quality of life using the EQ-5D-5L measure

  4. Estimate population statistics for each DTR - Length of hospital stay

    Time frame: Day 90

    Length of hospital stay post HAP diagnosis.

  5. Estimate population statistics for each DTR - Mortality

    Time frame: Day 14, 28 and 90

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

  6. Estimate number of eligible patients and the pattern of their presentation.

    Time frame: At end of study (15 months)

    Hospital/ward type, time of day/day of week.

  7. Estimate rates of successful follow up.

    Time frame: At end of study (15 months)

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

  8. Estimate rates of completion of questionnaires.

    Time frame: At end of study (15 months)

    EQ5D5L, CAP-sym, economic evaluation.

  9. Test the web-based randomisation process and incorporate clinical and researcher feedback.

    Time frame: During qualitative analysis throughout the study (up to 15 months)

    Qualitative conclusions based on staff focus groups.

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

    Time frame: At end of study (15 months)

    Summary statistics for numbers and types of costs with comparison between DTRs.

  11. 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.

    Time frame: During qualitative analysis throughout the study (up to 15 months)

    Qualitative conclusions based on staff focus groups.

  12. Evaluate willingness of clinicians to recruit to the study.

    Time frame: During qualitative analysis throughout the study (up to 15 months)

    Qualitative conclusions based on staff focus groups.

  13. Evaluate willingness of potential participants or their consultees to be recruited.

    Time frame: During qualitative analysis throughout the study (up to 15 months)

    Qualitative conclusions based on participant and carer interviews.

  14. Evaluate adherence to antibiotic guidelines and study protocol.

    Time frame: At end of study (15 months)

    Summary statistics relating to antibiotic use in the pilot study with a comparison between the DTRs.

  15. Assess the study participant and carer experience of participating in the study.

    Time frame: During qualitative analysis throughout the study (up to 15 months)

    Qualitative interviews.

Sponsors and collaborators

Lead sponsor

University of Liverpool

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study title

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

Acronym: HAP-FAST

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 2, 2022
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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