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临床试验/NCT05351242
NCT05351242尚未招募不适用

Thermotherapy Against Persistent Bacterial LUNG Infections

Chronic Obstructive Pulmonary Disease Trial Network, Denmark2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
2
主要终点
Changes in bacterial growth (measured in cfu/mL) from bronchoalveolar lavage after 6 months

研究概览

简要总结

The aim of this study is to determine whether an intervention with frequent thermotherapy will be able to reduce the amount of colonizing bacteria in the bronchoalveolar lavage sample and eradicate the colonizing bacteria.

详细描述

Normally, bacterial lung infections are acute such as community-acquired pneumonia and typically resolve after antibiotic therapy without leaving much lasting damage on the lungs. However, a great amount of persons with disrupted clearance of mucus and/or lung immune system get persistent lung infections, which can be life-long, usually do not resolve even with antibiotics, and can greatly increase morbidity and mortality. IThese persistent lung infections are thus characterized by stable periods with exacerbations inbetween, akin to chronic lung diseases such as asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis. In addition, it has not been thoroughly investigated whether antibiotic regimens have an effect on disease control, as biofilm formation prevents antibiotics from killing the bacteria.

This is a randomized, controlled, multi-center, superiority trial evaluating the effect of a thermotherapy intervention, consisting of min. 7 minutes stay in min. 85℃ environment at least 4 times a week for 6 months, in persons with persistent bacterial lung infection, defined as min. 2 positive cultures during the last 24 months for one of the following bacteria: Pseudomonas aeruginosa, Achromobacter xylosoxidans, Stenotrophomonas maltophilia, Klebsiella oxytoca, Klebsiella pneumoniae, Haemophilus influenzae or Staphylococcus aureus, incl. 1 positive culture after attempted eradication therapy. The aim of the study is to investigate whether thermotherapy may offer a valid proposal for treatment of chronic lung infections.

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

入选标准

  • Age ≥ 18 years
  • Competent and capable
  • FEV1>1,0 L
  • Have had a positive culture from sputum or BAL min. 2 times in the last 24 months for bacteria of the species: Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Staphylococcus aureus, Haemophilus influenzae, Achromobacter xylosoxidans, Klebsiella oxytoca or Klebsiella pneumoniae. In addition, min. 1 positive culture after treatment with antibiotics
  • Willing to go to a sauna (min. temperature of 85℃ for at least 7 minutes) four times weekly for six months or avoid going to a sauna for six months

排除标准

  • Allergy to lidocaine and/or midazolam
  • Contraindications to bronchoscopy
  • Previous severe laryngospasm (intubation requiring)
  • Pregnancy/breastfeeding
  • Severe linguistic problems or inability to give informed consent
  • Severe mental illness that is not controlled with medication. NB: Patients with controlled mental illness can be included and will be asked on an equal footing as others

研究组 & 干预措施

Thermotherapy/sauna bath

Experimental

Must go to a sauna (min. Temperature 85℃) min. 4 times a week for 6 months. Each sauna bath must last at least 7 minutes. The intervention patients receive a subscription card for a sauna during the period. Patients will still receive pre-existing treatment

干预措施: Thermotherapy/sauna bath (Other)

No thermotherapy/sauna bath

No Intervention

Not allowed to go to a sauna for 6 months. Patients who come to do so, by e.g. an oversight, however, remain in the study, to avoid introducing bias. It will be registered as a "protocol violation", but the patient will be included in Intention To Treat analysis and modified Intention To Treat analysis. Patients will still receive pre-existing treatment.

结局指标

主要结局

Changes in bacterial growth (measured in cfu/mL) from bronchoalveolar lavage after 6 months

时间窗: 6 months

Eradication of the cultured bacteria at baseline, defined by no use of antibiotics the last 14 days at the follow-up assessment after 6 months

时间窗: 6 months

次要结局

  • Physical performance measured by distance walked over 6 minutes(6 months)
  • Number of antibiotic treatment regimes within 6 months(6 months)
  • Number of hospitalizations for all causes or death within 6 months(6 months)
  • Changes in BMI after 6 months(6 months)
  • Clinically relevant changes in Chronic Obstructive Pulmonary Disease Assessment Test-score (range from 0-40, higher is worse) after 6 months(6 months)
  • Changes in status from Medical Research Council-dyspnea score (range from 0-5, higher is worse) from <3 to 3≥, after 6 months(6 months)
  • Changes in FEV1 after 6 months(6 months)
  • Changes in abundance of the lung microbiota after 6 months(6 months)
  • Changes in composition of the lung microbiota after 6 months(6 months)

研究者

发起方
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
申办方类型
Other
责任方
Sponsor

研究点 (2)

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