Transthoracic drainage of lung abscesses (TOLA): protocol for a national multicenter randomized open-label trial

Abstract

Introduction Lung abscess (LA) is a rare but severe necrotizing pulmonary infection associated with substantial morbidity and mortality. Current management relies on prolonged systemic antibiotic therapy without systematic use of abscess drainage. However, small case series and retrospective studies suggest that transthoracic drainage may be a safe and effective adjunctive intervention improving treatment response. Historically, drainage has been avoided for fear of fistulation, but evidence supporting this is weak. High-quality evidence from randomized trials regarding interventional treatment of LA is lacking. This trial aims to determine whether transthoracic drainage combined with standard antibiotic therapy reduces hospital stay, compared with standard antibiotics alone in patients with LA.Methods This is a national, multicentre, randomized open-label trial. Adults diagnosed with an LA ≥ 4 cm in diameter, containing fluid, and in contact with the outer third of the lung, will be eligible for the study. A total of 84 patients will be randomized 1:1 to either (1) transthoracic drainage combined with standard antibiotic treatment or (2) standard antibiotic treatment alone. Patients will undergo clinical assessments, laboratory testing, microbiological analyses, CT imaging, and standardized patient-reported outcome measures. Follow-up is scheduled at 1, 4, and 12 weeks post‑discharge. The primary outcome is length of hospital stay. Recruitment started February 2026 with an anticipated inclusion period of 4 years.Perspective This study will provide the first randomized evidence on the role of transthoracic drainage in LA management. The results may inform national and international clinical guidelines and improve outcomes in patients with this severe condition.Trial registration ClinicalTrial.gov (NCT07247461)