Transthoracic drainage of lung abscesses (TOLA): protocol for a national multicenter randomized open-label trial.
Katrine Kristensen, Uffe Bodtger, Søren Helbo Skaarup...
https://pubmed.ncbi.nlm.nih.gov/42591951/Actively Recruiting
Led by University of Aarhus · Updated on 2026-06-10
84
Participants Needed
1
Research Sites
34 weeks
Total Duration
Researchers are evaluating whether early drainage of lung abscesses combined with standard antibiotic treatment can shorten hospital stays compared to antibiotics alone. This trial involves adult patients hospitalized with lung abscesses larger than 4 cm near the lung surface. The study is a randomized controlled trial conducted across university hospitals in Denmark and aims to provide new evidence to improve treatment guidelines for this serious condition. Participants are randomly assigned to one of two groups one group receives a chest tube inserted into the abscess to drain pus along with intravenous antibiotics, while the other group receives intravenous antibiotics only. Drainage tubes are placed under imaging guidance and flushed three times daily. Both groups follow antibiotic treatment protocols, starting with intravenous piperacillintazobactam and transitioning to oral antibiotics once clinical improvement is observed. The intervention duration and tube removal depend on clinical and imaging criteria. During the hospital stay, participants complete health questionnaires and undergo routine scans, blood tests, and lung assessments. Pus and cheek swabs are collected for microbiological analysis. After discharge, follow-up includes a phone call at one week and in-person visits at 4 and 12 weeks with lung function tests, walk tests, questionnaires, CT scans, and blood tests. One year later, medical records are reviewed for long-term outcomes. The primary outcome measured is the length of hospital stay from admission to discharge.
CONDITIONS
Transthoracic Drainage of Lung Abscesses. A National Randomized Trial.
K
Katrine Kristensen, MD
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University of Aarhus
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to hospital discharge
Participants begin intravenous antibiotic treatment. Those in the drainage group receive a chest tube inserted into the lung abscess, which is flushed daily. Antibiotics are adjusted as needed. The drainage tube is removed when clinical and imaging criteria indicate improvement.
Daily monitoring during hospital stay
Duration - 12 months
After hospital discharge, participants have phone and in-person follow-up visits. These include symptom checks, blood tests, lung function tests, walk tests, health questionnaires, and CT scans at 1, 4, and 12 weeks. Medical records are reviewed at 1 year for long-term outcomes.
Phone call at 1 week; in-person visits at 4 and 12 weeks
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Katrine Kristensen, Uffe Bodtger, Søren Helbo Skaarup...
https://pubmed.ncbi.nlm.nih.gov/42591951/University of Aarhus
Lead Sponsor