Clinical trial NCT04569110: The Microbiology of Pleural Infection
Official title: The Bacteriology of Pleural Infection Using Next Generation Sequencing: The Oxford Pleural Infection Metagenomics Studies (TORPIDS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleural Infection
Pleural Infection Bacterial
Keywords: pleural
pleural infection
pleural effusion
microbiome
metagenomics
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients with pleural infection (PILOT cohort)
* Patients with pleural effusion but without pleural infection (negative control group)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Microbiome
timeFrame: Enrolement
Secondary outcomes:
measure: Association between bacterial patterns and clinical outcomes
timeFrame: 12 months for survival and requirement for surgical drainage
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Laboratory of Pleural Translational Research, Nuffield Department of Medicine, University of Oxford
state: Oxfordshire
Study officials:
References:
citation: Davies HE, Davies RJ, Davies CW; BTS Pleural Disease Guideline Group. Management of pleural infection in adults: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii41-53. doi: 10.1136/thx.2010.137000. No abstract available.
citation: Corcoran JP, Wrightson JM, Belcher E, DeCamp MM, Feller-Kopman D, Rahman NM. Pleural infection: past, present, and future directions. Lancet Respir Med. 2015 Jul;3(7):563-77. doi: 10.1016/S2213-2600(15)00185-X.
citation: Corcoran JP, Psallidas I, Gerry S, Piccolo F, Koegelenberg CF, Saba T, Daneshvar C, Fairbairn I, Heinink R, West A, Stanton AE, Holme J, Kastelik JA, Steer H, Downer NJ, Haris M, Baker EH, Everett CF, Pepperell J, Bewick T, Yarmus L, Maldonado F, Khan B, Hart-Thomas A, Hands G, Warwick G, De Fonseka D, Hassan M, Munavvar M, Guhan A, Shahidi M, Pogson Z, Dowson L, Popowicz ND, Saba J, Ward NR, Hallifax RJ, Dobson M, Shaw R, Hedley EL, Sabia A, Robinson B, Collins GS, Davies HE, Yu LM, Miller RF, Maskell NA, Rahman NM. Prospective validation of the RAPID clinical risk prediction score in adult patients with pleural infection: the PILOT study. Eur Respir J. 2020 Nov 26;56(5):2000130. doi: 10.1183/13993003.00130-2020. Print 2020 Nov.