Thermotherapy Against Persistent Bacterial LUNG Infections

NCT ID: NCT05351242

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2026-09-30

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 the colonizing bacteria.

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 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.

Conditions

Lung Diseases, Obstructive; Bronchiectasis; Asthma; Copd; Chronic Obstructive Pulmonary Disease; Chronic Lung Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Thermotherapy/sauna bath

Intervention Type: OTHER

Thermotherapy/sauna bath

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Thermotherapy/sauna bath

Thermotherapy/sauna bath

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chronic Obstructive Pulmonary Disease Trial Network, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Herlev and Gentofte University hospital

Hellerup, Capital Region, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Mohamad I Saeed, MD

Role: CONTACT

mohamad.isam.saeed.02@regionh.dk

+4538673555

Facility Contacts

Mohamad I Saeed, MD

Role: primary

mohamad.isam.saeed.02@regionh.dk

Other Identifiers

THERM-A-LUNG

Identifier Type: -

Identifier Source: org_study_id