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Recruiting NCT05394220

Metagenomic Study in Parapneumonic Effusion

Trial Parameters

Condition Parapneumonic Effusion
Sponsor Chinese University of Hong Kong
Study Type OBSERVATIONAL
Phase N/A
Enrollment 115
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-06-01
Completion 2026-05-31
Interventions
16S rRNA gene amplicon sequencing

Brief Summary

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.

Eligibility Criteria

Study group (patients with parapneumonic effusion) Inclusion Criteria: * Patients hospitalized for suspected pleural infection, irrespective of community-acquired or hospital-acquired in nature * Pleural tapping will be performed for pleural fluid analysis * Chinese ethnicity * Aged 18 years old or above Exclusion Criteria: * Use of antibiotics for more than 24 hours for the current episode of infection * On long-term local or systemic antibiotics * Tuberculous pleuritis * Pregnant or lactating women * Failed to obtain informed consent due to patient's refusal or cognitive impairment Control group (patients with effusions but not parapneumonic in nature) Inclusion Criteria: * Pleural effusion is not related to any infection including pneumonia (e.g. malignancy, fluid overload) * Pleural tapping will be performed for pleural fluid analysis * Chinese ethnicity * Aged 18 years old or above Exclusion Criteria: * The use of systemic (including oral and intravenous) and inhaled antibiotics i

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