Clinical trial NCT05351242: Thermotherapy Against Persistent Bacterial LUNG Infections
Official title: Thermotherapy Against Persistent Bacterial LUNG Infections
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Diseases, Obstructive
Bronchiectasis
Asthma
Copd
Chronic Obstructive Pulmonary Disease
Chronic Lung Infections
Lead sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in bacterial growth (measured in cfu/mL) from bronchoalveolar lavage after 6 months
timeFrame: 6 months
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Number of hospitalizations for all causes or death within 6 months
timeFrame: 6 months
measure: Number of antibiotic treatment regimes within 6 months
timeFrame: 6 months
measure: Physical performance measured by distance walked over 6 minutes
timeFrame: 6 months
measure: Changes in FEV1 after 6 months
timeFrame: 6 months
measure: Changes in BMI after 6 months
timeFrame: 6 months
measure: Clinically relevant changes in Chronic Obstructive Pulmonary Disease Assessment Test-score (range from 0-40, higher is worse) after 6 months
timeFrame: 6 months
measure: Changes in status from Medical Research Council-dyspnea score (range from 0-5, higher is worse) from <3 to 3≥, after 6 months
timeFrame: 6 months
measure: Changes in composition of the lung microbiota after 6 months
timeFrame: 6 months
measure: Changes in abundance of the lung microbiota after 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Herlev and Gentofte University hospital
state: Region Hovedstaden
Study officials:
References: