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Thermotherapy Against Persistent Bacterial LUNG Infections (THERM-A-LUNG)

Primary Purpose

Lung Diseases, Obstructive, Bronchiectasis, Asthma

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Thermotherapy/sauna bath
Sponsored by
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases, Obstructive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herlev and Gentofte University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Thermotherapy/sauna bath

No thermotherapy/sauna bath

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Changes in bacterial growth (measured in cfu/mL) from bronchoalveolar lavage after 6 months
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

Secondary Outcome Measures

Number of hospitalizations for all causes or death within 6 months
Number of antibiotic treatment regimes within 6 months
Physical performance measured by distance walked over 6 minutes
Changes in FEV1 after 6 months
Changes in BMI after 6 months
Clinically relevant changes in Chronic Obstructive Pulmonary Disease Assessment Test-score (range from 0-40, higher is worse) after 6 months
Changes in status from Medical Research Council-dyspnea score (range from 0-5, higher is worse) from <3 to 3≥, after 6 months
Changes in composition of the lung microbiota after 6 months
Changes in abundance of the lung microbiota after 6 months

Full Information

First Posted
April 19, 2022
Last Updated
August 30, 2023
Sponsor
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05351242
Brief Title
Thermotherapy Against Persistent Bacterial LUNG Infections
Acronym
THERM-A-LUNG
Official Title
Thermotherapy Against Persistent Bacterial LUNG Infections
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chronic Obstructive Pulmonary Disease Trial Network, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Obstructive, Bronchiectasis, Asthma, Copd, Chronic Obstructive Pulmonary Disease, Chronic Lung Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thermotherapy/sauna bath
Arm Type
Experimental
Arm Description
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
Arm Title
No thermotherapy/sauna bath
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Thermotherapy/sauna bath
Intervention Description
Thermotherapy/sauna bath
Primary Outcome Measure Information:
Title
Changes in bacterial growth (measured in cfu/mL) from bronchoalveolar lavage after 6 months
Time Frame
6 months
Title
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of hospitalizations for all causes or death within 6 months
Time Frame
6 months
Title
Number of antibiotic treatment regimes within 6 months
Time Frame
6 months
Title
Physical performance measured by distance walked over 6 minutes
Time Frame
6 months
Title
Changes in FEV1 after 6 months
Time Frame
6 months
Title
Changes in BMI after 6 months
Time Frame
6 months
Title
Clinically relevant changes in Chronic Obstructive Pulmonary Disease Assessment Test-score (range from 0-40, higher is worse) after 6 months
Time Frame
6 months
Title
Changes in status from Medical Research Council-dyspnea score (range from 0-5, higher is worse) from <3 to 3≥, after 6 months
Time Frame
6 months
Title
Changes in composition of the lung microbiota after 6 months
Time Frame
6 months
Title
Changes in abundance of the lung microbiota after 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamad I Saeed, MD
Phone
+4538673555
Email
mohamad.isam.saeed.02@regionh.dk
Facility Information:
Facility Name
Herlev and Gentofte University hospital
City
Hellerup
State/Province
Region Hovedstaden
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamad I Saeed, MD
Email
mohamad.isam.saeed.02@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Thermotherapy Against Persistent Bacterial LUNG Infections

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