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

Sponsor
University of Liverpool (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05483309
Collaborator
National Institute for Health Research, United Kingdom (Other)
220
4
23

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: CT scan
  • Diagnostic Test: FilmArray Pneumonia Panel
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Feasibility Study of the Clinical and Cost-effectiveness of Contemporary Diagnostics for Patients With Suspected Hospital-Acquired Pneumonia (HAP).
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostic Treatment Regimen 1

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

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

No Intervention: Diagnostic Treatment Regimen 2

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

Experimental: Diagnostic Treatment Regimen 3

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

Diagnostic Test: CT scan
Patients receive a CT scan

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

Experimental: Diagnostic Treatment Regimen 4

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

Diagnostic Test: CT scan
Patients receive a CT scan

Outcome Measures

Primary Outcome Measures

  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. [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 Outcome Measures

  1. Estimate population statistics for each DTR - Time to clinical cure [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 [Day 90]

    Antibiotic usage for the HAP episode

  3. Estimate population statistics for each DTR - Change to Quality of Life [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 [Day 90]

    Length of hospital stay post HAP diagnosis.

  5. Estimate population statistics for each DTR - Mortality [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. [At end of study (15 months)]

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

  7. Estimate rates of successful follow up. [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. [At end of study (15 months)]

    EQ5D5L, CAP-sym, economic evaluation.

  9. Test the web-based randomisation process and incorporate clinical and researcher feedback. [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. [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. [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. [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. [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. [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. [During qualitative analysis throughout the study (up to 15 months)]

    Qualitative interviews.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Liverpool
  • National Institute for Health Research, United Kingdom

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Liverpool
ClinicalTrials.gov Identifier:
NCT05483309
Other Study ID Numbers:
  • UoL001676
First Posted:
Aug 2, 2022
Last Update Posted:
Aug 2, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022