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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05351242
Other study ID # THERM-A-LUNG
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 31, 2023
Est. completion date September 2026

Study information

Verified date August 2023
Source Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Contact Mohamad I Saeed, MD
Phone +4538673555
Email mohamad.isam.saeed.02@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 amount of persons with disrupted clearance of mucus and/or lung immune system get persistent lung infections, which can be life-long, usually do not resolve even with antibiotics, and can greatly increase morbidity and mortality. IThese persistent lung infections are thus characterized by stable periods with exacerbations inbetween, akin to chronic lung diseases such as asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis. In addition, it has not been thoroughly investigated whether antibiotic regimens have an effect on disease control, as biofilm formation prevents antibiotics from killing the bacteria. This is a randomized, controlled, multi-center, superiority trial evaluating the effect of a thermotherapy intervention, consisting of min. 7 minutes stay in min. 85℃ environment at least 4 times a week for 6 months, in persons with persistent bacterial lung infection, defined as min. 2 positive cultures during the last 24 months for one of the following bacteria: Pseudomonas aeruginosa, Achromobacter xylosoxidans, Stenotrophomonas maltophilia, Klebsiella oxytoca, Klebsiella pneumoniae, Haemophilus influenzae or Staphylococcus aureus, incl. 1 positive culture after attempted eradication therapy. The aim of the study is to investigate whether thermotherapy may offer a valid proposal for treatment of chronic lung infections.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date September 2026
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Thermotherapy/sauna bath
Thermotherapy/sauna bath

Locations

Country Name City State
Denmark Herlev and Gentofte University hospital Hellerup Region Hovedstaden

Sponsors (1)

Lead Sponsor Collaborator
Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in bacterial growth (measured in cfu/mL) from bronchoalveolar lavage after 6 months 6 months
Primary Eradication of the cultured bacteria at baseline, defined by no use of antibiotics the last 14 days at the follow-up assessment after 6 months 6 months
Secondary Number of hospitalizations for all causes or death within 6 months 6 months
Secondary Number of antibiotic treatment regimes within 6 months 6 months
Secondary Physical performance measured by distance walked over 6 minutes 6 months
Secondary Changes in FEV1 after 6 months 6 months
Secondary Changes in BMI after 6 months 6 months
Secondary Clinically relevant changes in Chronic Obstructive Pulmonary Disease Assessment Test-score (range from 0-40, higher is worse) after 6 months 6 months
Secondary Changes in status from Medical Research Council-dyspnea score (range from 0-5, higher is worse) from <3 to 3=, after 6 months 6 months
Secondary Changes in composition of the lung microbiota after 6 months 6 months
Secondary Changes in abundance of the lung microbiota after 6 months 6 months
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