The Oxford Pleural Infection Endotyping Study

NCT06513689 | Completed DMC

• 1 other identifier: R74885/RE001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Pleural infection is a severe disease with increasing incidence worldwide. The subphenotypes of pleural infection remain unknown.We designed a study to endotype the disease and assess the association between patient phenotype, microbiology and clinical outcome. We subjected 80 pleural fluid samples to unlabelled mass spectrometry. Pathway analysis of the differentially expressed proteins identified the neutrophil degranulation, glycolysis, pentose phosphate pathway, and the liver and retinoid X receptors (LXR-RXR) activation. Higher neutrophil degranulation was associated with increased glycolysis and pentose phosphate activation. Pleural infection patients exhibit proteomic signatures indicating diverse responses of neutrophil mediated immunity, glycolysis, and pentose phosphate activation.

Conditions

Pleural Infection; Pleural Diseases; Pleural Effusion; Pleural Empyema; Pleural Infection Bacterial; Pleural Infections and Inflammations

Keywords

pleural; pleural infection; respiratory; neutrophils

Outcome Measures

Primary Outcomes (3)

• Pleural infection endotypes

  Discovery of pleural infection biological endotypes

  12 months

• Association between endotypes and microbiology

  Investigate the association between pleural infection endotypes and microbiology

  12 months

• Association between endotypes and one-year survival

  Investigate the association between pleural infection endotypes and one-year survival

  12 months

Secondary Outcomes (2)

• Association between endotypes and need for surgical treatment

  12 months

• Association between levels of pleural fluid plasminogen and neutrophil elastase

  12 months

Study Arms (1)

Enrolment

All samples were collect at patient enrolment for the PILOT study (PMID: 32675200, ISRCTN 50236700)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with evidence of pleural infection

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Laboratory of Pleural Translational Research, Nuffield Department of Medicine, University of Oxford

Oxford, Oxfordshire, OX3 7FZ, United Kingdom

Location

Related Publications (1)

• "Prospective validation of the RAPID clinical risk prediction score in adult patients with pleural infection: the PILOT study." John P. Corcoran, Ioannis Psallidas, Stephen Gerry, Francesco Piccolo, Coenraad F. Koegelenberg, Tarek Saba, Cyrus Daneshvar, Ian Fairbairn, Richard Heinink, Alex West, Andrew E. Stanton, Jayne Holme, Jack A. Kastelik, Henry Steer, Nicola J. Downer, Mohammed Haris, Emma H. Baker, Caroline F. Everett, Justin Pepperell, Thomas Bewick, Lonny Yarmus, Fabien Maldonado, Burhan Khan, Alan Hart-Thomas, Georgina Hands, Geoffrey Warwick, Duneesha De Fonseka, Maged Hassan, Mohammed Munavvar, Anur Guhan, Mitra Shahidi, Zara Pogson, Lee Dowson, Natalia D. Popowicz, Judith Saba, Neil R. Ward, Rob J. Hallifax, Melissa Dobson, Rachel Shaw, Emma L. Hedley, Assunta Sabia, Barbara Robinson, Gary S. Collins, Helen E. Davies, Ly-Mee Yu, Robert F. Miller, Nick A. Maskell and Najib M. Rahman. Eur Respir J 2020; 56: 2000130. Eur Respir J. 2020 Dec 17;56(6):2050130. doi: 10.1183/13993003.50130-2020. Print 2020 Dec. No abstract available.

  PMID: 33334780 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Acellular pleural fluid specimens

MeSH Terms

Conditions

Pleural Diseases; Pleural Effusion; Empyema, Pleural; Inflammation

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Empyema; Suppuration; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: June 20, 2021
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

GB (1)