Status:
RECRUITING
Thermotherapy Against Persistent Bacterial LUNG Infections
Lead Sponsor:
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Conditions:
Lung Diseases, Obstructive
Bronchiectasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 th...
Detailed Description
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 amo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05351242
Start Date
January 31 2023
End Date
September 1 2026
Last Update
August 31 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Herlev and Gentofte University hospital
Hellerup, Capital Region, Denmark, 2900