Thermotherapy Against Persistent Bacterial LUNG Infections

Asthma Clinical Trial

— THERM-A-LUNG  

Official title:

Thermotherapy Against Persistent Bacterial LUNG Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05351242
• Other study ID #: THERM-A-LUNG
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Asthma
• Bronchiectasis
• Chronic Obstructive Pulmonary Disease
• Communicable Diseases
• Copd
• Infections
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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