THERMotherapy Against Persistent Bacterial LUNG Infections
Denmark150 participantsStarted 2026-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'not yet recruiting' — do you know when it might open, and is it worth waiting for it versus starting standard treatment now?
2The trial is measuring how many days I can go without needing antibiotics for my lung infection — given how frequently I currently need antibiotics, does that sound like a meaningful goal for my situation?
3The trial is listed as Phase NA, which suggests it may be a device or procedure study rather than a drug trial — can you explain what the thermotherapy treatment actually involves and what risks it might carry for someone with my specific condition, whether that's bronchiectasis, COPD, or asthma?
4Since this trial targets persistent bacterial lung infections, how would my doctors confirm I actually have a chronic bacterial infection that would make me a realistic candidate for this kind of study?
5Are there established treatments for my chronic lung infection that I should try first, or is a study like this something worth considering earlier in my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of days from baseline without antibiotic treatment against pulmonary infection