The Microbiology of Pleural Infection

Completed

• Conditions: Pleural Infection; Pleural Infection Bacterial
• Interventions: Other: Not applicable. Observational study. Retrospective analysis of samples.

• Registration Number: NCT04569110
• Lead Sponsor: University of Oxford

Brief Summary

Pleural Infection (PI) is a common, severe and complicated disease with considerable morbidity and mortality. (1,2) The knowledge of pleural infection microbiology remains incomplete. Sequencing of the bacterial 16S rRNA gene is a reliable methodology to discover the total microbiome of complex samples.

The investigators designed a translational metagenomics study to study the bacteriology of pleural infection. The investigators will use pleural fluid specimens from a) the "Prospective validation of the RAPID clinical risk prediction score in adult patients with pleural infection: the PILOT study" (3) clinical trial and b) non-pleural infection patients. The pleural fluid specimens will be subjected to 16S rRNA next generation sequencing.

Detailed Description

Pleural Infection (PI) is a common, severe and complicated disease with considerable morbidity and mortality1,2. Patients develop pleural effusions of frankly infected fluid. The understanding of pleural infection microbiome could improve patient clinical management, however the knowledge remains incomplete. Sequencing of the bacterial 16S rRNA gene is a reliable methodology to discovery the total microbiome of complex samples.

The investigators designed a translational study to study the bacteriology of pleural infection. Pleural fluid specimens from a) the "Prospective validation of the RAPID clinical risk prediction score in adult patients with pleural infection: the PILOT study" (3) clinical trial and b) non-pleural infection patients will be subjected to bacterial DNA extraction followed by 16S rRNA next generation sequencing. Moreover, the investigators will study the association between bacterial patterns and important clinical outcomes including survival, duration of hospitalisation and need for surgery.

Study Timeline

• Study Start: 2019-02-10
• Primary Completion: 2020-06-30
• Study Completion: 2020-08-31
• Status Verified: 2020-09
• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-29
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

• As per protocol of the "Prospective validation of the RAPID clinical risk prediction score in adult patients with pleural infection: the PILOT study". PMID: 32675200 DOI: 10.1183/13993003.00130-2020

Exclusion Criteria

• As per protocol of the "Prospective validation of the RAPID clinical risk prediction score in adult patients with pleural infection: the PILOT study". PMID: 32675200 DOI: 10.1183/13993003.00130-2020

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Negative control	Not applicable. Observational study. Retrospective analysis of samples.	Patients without pleural infection.
Pleural infection	Not applicable. Observational study. Retrospective analysis of samples.	Patients with clinically confirmed ongoing pleural infection.

Primary Outcome Measures

Name	Time	Method
Microbiome	Enrolement	Discover the microbiome of each sample

Secondary Outcome Measures

Name	Time	Method
Association between bacterial patterns and clinical outcomes	12 months for survival and requirement for surgical drainage	Study the association between the microbiome and clinical outcomes

Trial Locations

Locations (1)

Laboratory of Pleural Translational Research, Nuffield Department of Medicine, University of Oxford; 🇬🇧 Oxford, Oxfordshire, United Kingdom