TORPIDS: The Microbiology of Pleural Infection

Sponsor
University of Oxford (Other)
Overall Status
Completed
CT.gov ID
NCT04569110
Collaborator
(none)
251
1
18.7
13.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Not applicable. Observational study. Retrospective analysis of samples.

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 Design

Study Type:
Observational
Actual Enrollment :
251 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Bacteriology of Pleural Infection Using Next Generation Sequencing: The Oxford Pleural Infection Metagenomics Studies (TORPIDS)
Actual Study Start Date :
Feb 10, 2019
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Aug 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Pleural infection

Patients with clinically confirmed ongoing pleural infection.

Other: Not applicable. Observational study. Retrospective analysis of samples.
Not applicable. Observational study. Retrospective analysis of samples.

Negative control

Patients without pleural infection.

Other: Not applicable. Observational study. Retrospective analysis of samples.
Not applicable. Observational study. Retrospective analysis of samples.

Outcome Measures

Primary Outcome Measures

  1. Microbiome [Enrolement]

    Discover the microbiome of each sample

Secondary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Laboratory of Pleural Translational Research, Nuffield Department of Medicine, University of Oxford Oxford Oxfordshire United Kingdom OX3 7FZ

Sponsors and Collaborators

  • University of Oxford

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Oxford
ClinicalTrials.gov Identifier:
NCT04569110
Other Study ID Numbers:
  • 248005
First Posted:
Sep 29, 2020
Last Update Posted:
Oct 1, 2020
Last Verified:
Sep 1, 2020
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:
No
Keywords provided by University of Oxford
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 1, 2020