Actively Recruiting

Age: 18Years +
All Genders
NCT05394220

Metagenomic Study in Parapneumonic Effusion

Led by Chinese University of Hong Kong · Updated on 2023-06-29

115

Participants Needed

1

Research Sites

208 weeks

Total Duration

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AI-Summary

What this Trial Is About

Objective: To identify known and unknown bacterial pathogens in patients with pleural infections using a combination of conventional culture and next-generation sequencing approaches. Hypothesis to be tested: The investigators hypothesize that next-generation sequencing will serve as a comprehensive approach to identify culturable and unculturable bacterial pathogens in patients with pleural infections compared to the conventional culture. Design and subjects: This is a prospective cohort study to be conducted in the medical department of a tertiary care hospital in Hong Kong involving patients with pleural infection. Patients will be recruited if a pleural infection is suspected, with pleural fluid sampled and a 6-month follow-up. The clinical management by the medical team will not be interfered. Study instruments: Pleural fluid will be collected for conventional culture, 16S amplicon and shotgun metagenomic sequencing in parallel. The clinical information will be collected to clarify the causative correlation between symptoms, clinical outcomes and pathogen infections. Main outcome measures: The full spectrum of causative bacteria in pleural infection will be characterized. The diagnostic performance of identifying causative bacteria in pleural infection will be compared between the studied methods. The antimicrobial resistance pattern, clinical outcomes of pleural infection will also be compared between groups as categorized by the pattern of bacteriology identified by different methods. Data analysis: With reference to the conventional culture as the gold standard, sensitivity, specificity, positive predictive values and negative predictive values of 16S ribosomal ribonucleic acid (rRNA) gene amplicon and shotgun metagenomic sequencing will be calculated.

CONDITIONS

Official Title

Metagenomic Study in Parapneumonic Effusion

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients hospitalized for suspected pleural infection, regardless of where the infection was acquired
  • Pleural fluid sampling (pleural tapping) will be performed for analysis
  • Chinese ethnicity
  • Aged 18 years or older
  • For control group: Pleural effusion not caused by infection (e.g., cancer, fluid overload)
  • Control group also requires pleural fluid sampling, Chinese ethnicity, and age 18 or older
Not Eligible

You will not qualify if you...

  • Use of antibiotics for more than 24 hours for the current infection episode
  • Use of long-term local or systemic antibiotics
  • Tuberculous pleuritis
  • Pregnant or lactating women
  • Unable to give informed consent due to refusal or cognitive impairment
  • For control group: Use of systemic or inhaled antibiotics in the past 1 month

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chinese University of Hong Kong

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

K

Ka Pang Chan, MBChB

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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