Transthoracic Drainage of Lung Abscesses. A National Randomized Trial.
TOLA
TOLA: Transthoracic Drainage of Lung Abscesses. A National Randomized Trial
1 other identifier
interventional
84
0 countries
N/A
Brief Summary
This study aims to investigate if early drainage of lung abscesses, in addition to standard antibiotic treatment, leads to shorter length of hospital stay. Study Design This is a randomized, controlled clinical trial. That means participants will be randomly assigned to one of two groups:
- Fill out two short health questionnaires at the start and during follow-up.
- Have relevant medical history collected from their hospital records.
- Undergo routine scans (CT), blood tests, and lung assessments as part of standard care.
- A cheek swab will be taken from all participants to study mouth bacteria.. For those receiving drainage the pus from the lung abscess will be collected for microbiological analysis. Microbiology samples will be stored in a research biobank and destroyed after analysis. Follow-up after discharge
- 1 week: A phone call to check symptoms and infection levels via a blood test.
- 4 and 12 weeks later: In-person checkups at the lung clinic, including:
- 6-minute walk test
- Lung function test
- Repeat health questionnaires
- CT scan
- Blood tests (up to 20 ml in total over the study)
- 1 years: Medical records are reviewed to asses morbidity and mortality. Participants The study will include 84 adult patients who are hospitalized with a lung abscess larger than 4 cm, located near the outer part of the lung. Inclusion will take place at five university hospitals in Denmark Why This Study Matters There are no official guidelines for treating lung abscesses, and research is limited. This study could offer vital new insights that help update treatment recommendations in Denmark and internationally. Because all five Danish regions are involved, the results could quickly be implemented into daily practice, improving care for future patients with this serious condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2025
CompletedFirst Posted
Study publicly available on registry
November 25, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2028
November 25, 2025
September 1, 2025
2 years
October 1, 2025
November 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of hospital stay
Primary outcome is length of hospital stay from admission to discharge measured in days.
From the patient is admitted to the hospital (day one) to the patient is discharged
Study Arms (2)
Transthoracic drainage
ACTIVE COMPARATORPatients in this arm will receive a Transthoracic drainage in their lung abscess in combination with standard treatment with IV antibiotics
Control group
NO INTERVENTIONPatients in this arm will receive standard treatment will IV antibiotics
Interventions
Patients randomized to the intervention arm will receive a Transthoracic drain in their lung abscess.
Eligibility Criteria
You may qualify if:
- Age \>18 years.
- Signed informed consent.
- CT scan compatible with LA (one or more cavitating lesions with liquid content).
- Clinical findings suggestive of ongoing infection.
- Lung abscess size ≥ 4 cm in diameter.
- Imaging indicates that the abscess contains fluid.
- The abscess involves the outer one-third of the lung.
You may not qualify if:
- Brest feeding.
- Predicted survival of less than 3 months.
- Known tuberculosis or non-tuberculous mycobacteriosis.
- Known chronic pulmonary aspergillosis.
- Patients with a primary suspicion of lung cancer
- Recent (\<3 months) contact with health facilities outside Scandinavia.
- Patients in whom anticoagulant treatment cannot be discontinued, or in whom the treatment pause does not allow drainage within 72 hours.
- Coagulopathy or other increased bleeding risk that cannot be corrected to allow drainage within 72 hours.
- Hemodynamic and/or respiratory unstable patient.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2025
First Posted
November 25, 2025
Study Start
January 1, 2026
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
August 30, 2028
Last Updated
November 25, 2025
Record last verified: 2025-09