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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermotherapy/sauna bath | Other | Thermotherapy/sauna bath |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of days from baseline without antibiotic treatment against pulmonary infection | This is a measure of infectious exacerbations. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hospitalizations for all causes or death within 6 months | 6 months | |
| Changes in antibiotic usage | 6 months | |
| Number of antibiotic treatment regimes within 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josefin V Eklöf, MD | Contact | 38673555 | +45 | josefin.viktoria.ekloef@regionh.dk |
| Jens-Ulrik S Jensen, Professor | Contact | 38673057 | +45 | jens.ulrik.jensen@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev and Gentofte University hospital | Hellerup | Capital Region | 2900 | Denmark |
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| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D001987 | Bronchiectasis |
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D006979 | Hyperthermia, Induced |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 6 months |
| Eradication of the cultured bacteria at baseline, defined by a) absence of the trial inclusion bacteria or b) the participant cannot expectorate dure to dry airways. | Absence of bacteria, which lead to inclusion, is measured by a min. of 3 consecutive expectorates with a min. of 24 hours in between. | 6 months |
| Physical performance measured by distance walked over 6 minutes | 6 months |
| Changes in FEV1 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 |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |