Predicting the outcomes from acute lower respiratory tract infections at the point of need

Not Applicable

Completed

• Conditions: Sepsis in patients with lower respiratory tract infections; Infections and Infestations

• Registration Number: ISRCTN96762081
• Lead Sponsor: Portsmouth Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-04-30
• Study Start: 2024-07-11
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Patients aged over 18 years
2. Patients admitted to hospital with symptoms associated with ALRTI
3. Have objective signs of acute lower respiratory tract infection as denoted by ONLY ONE of the following criteria:
3.1. New oxygen requirement
3.2. Clinical signs of acute lung infiltration or consolidation e.g. crackles, dullness to percussion, aegophony
3.3. Radiological signs of new lung infiltrates or consolidation

Exclusion Criteria

1. Patients <18 years of age
2. Pregnant patients
3. Patients with severe anaemia, defined as a haemoglobin less than 80 g/l at presentation
4. Patients with prior oxygen dependency due to chronic lung disease with chronic respiratory failure.
5. Immunosuppressed patients (e.g. HIV disease, anti-rejection medication)
6. Patients admitted for palliation only, or not expected to survive longer than 24 hours from ED attendance
7. Patients who already meet the criteria for sepsis at the time of hospital presentation
8. Recruitment to another study already at the time of presentation that would result in duplication of blood sampling

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The accuracy of the GADx multi-channel lateral flow device to detect bacterial infection and differentiate it from viral infection or no infection, measured using proteomic host-response biomarker signatures at a single time point within 24 hours of presentation to the hospital<br>2. The accuracy of Presymptom Health host response signature to predict sepsis, measured using 7-gene and 14-gene transcriptome signatures within 24 hours of presentation to the hospital, and daily up to 3 days thereafter<br>3. Biomarker signatures to predict organ dysfunction in all ALTRI patients, COVID-19+ve patients and COVID-19-ve patients, measured using 7-gene and 14-gene transcriptome signatures within 24 hours of presentation to the hospital, and daily up to 3 days thereafter

Secondary Outcome Measures

Name	Time	Method
1. Differences in biomarker signatures between COVID-19+ve and COVID-19-ve ALTRIs, measured using GADx proteomic and Presmyptom transcriptome signatures once within 24 hours of presentation to the hospital<br>2. Comparison of gene expression biomarkers with other known sepsis biomarker trajectories and illness severity scores to predict adverse outcomes in ALTRIs, measured using comparative proADM, IL-6, IL-8, IL-10, CRP and procalcitonin levels, measured within 24 hours of presentation to the hospital, and daily up to 3 days thereafter<br>3. The ability of GADx point of care multi-channel lateral flow technology to predict disease progression to sepsis, measured using proteomic host-response biomarker signatures at a single time point (initial presentation to the hospital)