Trials / Recruiting
RecruitingNCT05351242
Thermotherapy Against Persistent Bacterial LUNG Infections
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Chronic Obstructive Pulmonary Disease Trial Network, Denmark · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Lung Diseases, Obstructive
- Bronchiectasis
- Asthma
- Copd
- Chronic Obstructive Pulmonary Disease
- Chronic Lung Infections
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Thermotherapy/sauna bath | Thermotherapy/sauna bath |
Timeline
- Start date
- 2023-01-31
- Primary completion
- 2025-01-01
- Completion
- 2026-09-01
- First posted
- 2022-04-28
- Last updated
- 2023-08-31
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT05351242. Inclusion in this directory is not an endorsement.