TOLA: Transthoracic Drainage of Lung Abscesses. A National Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Length of hospital stay
研究概览
简要总结
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:
- Drainage group: Receives a chest tube (drain) inserted through the chest wall into the abscess in combination with standard intravenous antibiotics.
- Control group: Receives standard intravenous antibiotics only
Each participant has a 50/50 chance of being placed in either group.
During Hospital Stay All participants will begin treatment with intravenous antibiotics (piperacillin/tazobactam). If assigned to the drainage group, a trained medical team will insert a small tube into the abscess to drain the pus. The tube is flushed three times a day with sterile saline.
Participants will also:
- 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
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1 week: A phone call to check symptoms and infection levels via a blood test.
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4 and 12 weeks later: In-person checkups at the lung clinic, including:
-
6-minute walk test
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Lung function test
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Repeat health questionnaires
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CT scan
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Blood tests (up to 20 ml in total over the study)
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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.
详细描述
Trial design, setting and time frame The study is a multicentre, national, randomized controlled, open-label trial involving respiratory departments at university hospitals across all regions of Denmark. Patient enrollment is expected to to beguin early 2026 and continue for a 2-year period, concluding in early 2028.
Eligibility criteria Patients are eligible for inclusion to the study if they are above 18 years of age and admitted to the hospital with a lung abscess (LA) equal or larger than 4 cm containing fluid and in contact with the outer 1/3 of the lung.
Patients can be screened for eligibility at any hospital in Denmark. If the patient is eligible for inclusion and accepts participation in the study, the patient will be transferred to the respiratory department at the regional university hospital where randomization and inclusion will be performed.
Intervention - drainage Transthoracic drainage (TTD) will be initiated as soon as possible in the intervention group and within 72 hours of inclusion and randomization. Insertion of a drainage tube will be guided by ultrasound or computed tomography, decided by the operator case-by-case. Discontinuation of anticoagulant treatment and local anesthetics will be applied according to local guidelines. Choice of tube type (seldinger, one-step) will be decided by the operator. In cases where multiple LA are present, a tube will be placed in the largest LA accessible for drainage. If the tube is accidentally removed, indication for reinsertion will be decided by the treating physician.
The tube will be assessed daily and flushed three times daily with saline to ensure patency. Daily monitoring and documentation of chest tube input and output will be conducted, supplemented by a brief assessment of symptoms related to drainage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pregnancy. Prior to inclusion of fertile women, a negative pregnancy test must be available.
- •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.
研究组 & 干预措施
Transthoracic drainage
Patients in this arm will receive a Transthoracic drainage in their lung abscess in combination with standard treatment with IV antibiotics
干预措施: Transthoracic drainage (Procedure)
Control group
Patients in this arm will receive standard treatment will IV antibiotics
结局指标
主要结局
Length of hospital stay
时间窗: From the patient is admitted to the hospital (day one) to the patient is discharged
Primary outcome is length of hospital stay from admission to discharge measured in days.
次要结局
未报告次要终点