RECRUITINGINTERVENTIONAL
Thermotherapy Against Persistent Bacterial LUNG Infections
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- Allergy to lidocaine and/or midazolam
- Contraindications to bronchoscopy
- Previous severe laryngospasm (intubation requiring)
- Pregnancy/breastfeeding
- Severe linguistic problems or inability to give willing to sign a consent form
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
OTHER
Thermotherapy/sauna bath
Thermotherapy/sauna bath
Locations (1)
Herlev and Gentofte University hospital
Hellerup, Capital Region, Denmark