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NCT Number: NCT04569110

The Microbiology of Pleural Infection

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.

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Key information

Conditions

Pleural Infection Pleural Diseases Pleural Effusion Pleural Infection Bacterial Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Oxford, Oxfordshire, OX3 7FZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

The pleural fluid specimens were collected for 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. The investigators analysed the samples retrospectively.

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

Treatment and study plan

Not applicable. Observational study. Retrospective analysis of samples.

Other

Not applicable. Observational study. Retrospective analysis of samples.

Primary outcomes

  1. Microbiome

    Time frame: Enrolement

    Discover the microbiome of each sample

Secondary outcomes

  1. Association between bacterial patterns and clinical outcomes

    Time frame: 12 months for survival and requirement for surgical drainage

    Study the association between the microbiome and clinical outcomes

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

The Bacteriology of Pleural Infection Using Next Generation Sequencing: The Oxford Pleural Infection Metagenomics Studies (TORPIDS)

Acronym: TORPIDS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 29, 2020
Registry last updated
Oct 1, 2020

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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