RecruitingNot ApplicableNCT05351242
Thermotherapy Against Persistent Bacterial LUNG Infections
Sponsor
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Enrollment
150 participants
Start Date
Jan 31, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria6
- 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
Interventions
OTHERThermotherapy/sauna bath
Thermotherapy/sauna bath
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05351242
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