Thermotherapy Against Persistent Bacterial LUNG Infections

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Herlev and Gentofte University hospital
RECRUITING
Hellerup
Contact Information
Primary
Mohamad I Saeed, MD
mohamad.isam.saeed.02@regionh.dk
+4538673555
Time Frame
Start Date: 2023-01-31
Estimated Completion Date: 2026-09
Participants
Target number of participants: 150
Treatments
Experimental: Thermotherapy/sauna bath
Must go to a sauna (min. Temperature 85℃) min. 4 times a week for 6 months. Each sauna bath must last at least 7 minutes. The intervention patients receive a subscription card for a sauna during the period. Patients will still receive pre-existing treatment
No_intervention: No thermotherapy/sauna bath
Not allowed to go to a sauna for 6 months. Patients who come to do so, by e.g. an oversight, however, remain in the study, to avoid introducing bias. It will be registered as a protocol violation, but the patient will be included in Intention To Treat analysis and modified Intention To Treat analysis. Patients will still receive pre-existing treatment.
Sponsors
Leads: Chronic Obstructive Pulmonary Disease Trial Network, Denmark

This content was sourced from clinicaltrials.gov