Global point prevalence study to determine the variations in aetiology, management and outcomes of pleural infection: a protocol for the international multicentre study of pleural infection (the INTERMITTENT Study)

INTRODUCTION: Pleural infection is a common problem associated with a high mortality. The aim of this study is to address current knowledge gaps in this condition by describing the global burden of disease and assessing the regional and seasonal variation in causative organisms, demographic characteristics, clinical presentation, comorbidities, pleural effusion characteristics, management strategies and outcomes. These data will inform future research and management guidelines.

METHODS AND ANALYSIS: We will conduct an international multicentre point prevalence survey at two seasonal time points during the year. At each seasonal time point, data will be collected for 4 weeks on every episode of pleural infection presenting to the sites. Important demographic characteristics, medical history, clinical and imaging features, laboratory results, treatments and outcomes will be collected and analysed with a combination of descriptive and inferential statistics.

ETHICS AND DISSEMINATION: The study will be performed in accordance with the Declaration of Helsinki and the International Conference on Harmonisation/Good Clinical Practice. This trial received ethical approval from the Comitato Etico Regione March, Italy, Prot. 2024 266. Institutional approvals will be acquired at all sites. All data will be treated confidentially and collected anonymously into an access-controlled electronic database. Results will be disseminated at conferences and in peer-reviewed publications.