About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Allergy to lidocaine and/or midazolam
Contraindications to bronchoscopy
Previous severe laryngospasm (intubation requiring)
Pregnancy/breastfeeding
Trial design
Parallel
Treatments tested in this trial
Thermotherapy/sauna bath
Other interventionThermotherapy/sauna bath
Treatment groups
Trial outcomes
Primary outcomes
Number of days from baseline without antibiotic treatment against pulmonary infection
This is a measure of infectious exacerbations.
Secondary outcomes
Number of hospitalizations for all causes or death within 6 months
Changes in antibiotic usage
Number of antibiotic treatment regimes within 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.
Sponsors and contacts
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